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Ultraprocessed food again linked to increased CVD, death
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Yet another study has linked the consumption of ultraprocessed, or “junk,” foods to bad health outcomes.
In a longitudinal analysis of more than 22,000 men and women from southern Italy, those who consumed the most ultraprocessed food (UPF) had the highest risk for cardiovascular disease (CVD) and all-cause mortality, likely mediated through a diet high in sugar, researchers said.
High consumption of UPF in this Mediterranean cohort was associated with a 58% increased risk for CVD mortality and 52% higher risk of dying from ischemic heart disease (IHD) and cerebrovascular causes, independently of known risk factors for CVD, even among individuals who otherwise adhered to the Mediterranean diet.
The findings “should serve as an incentive for limiting consumption of UPF and encouraging natural or minimally processed foods, as several national nutritional policies recommend,” Marialaura Bonaccio, PhD, department of epidemiology and prevention, IRCCS Neuromed, Pozzilli, Italy, and colleagues wrote. The results were published online Dec. 18 in the American Journal of Clinical Nutrition.
Earlier this year, as reported by this news organization, researchers found mounting evidence that the obesity epidemic and the increase in incidence of related chronic conditions corresponded with an increase in the intake of UPF.
A study that was conducted in a European cohort found that adults whose diet included more UPF and beverages, such as ice cream, soda, and hamburgers, were more likely to develop CVD or die sooner than others who had a more wholesome diet.
As reported previously by this news organization, among adults in France who had a 10% higher intake of UPF and beverages, the rate of CVD, coronary heart disease, and cerebrovascular disease was 11% to 13% higher over a period of about 5 years.
Similarly, university graduates in Spain who consumed more than four servings of UPF and beverages a day were 62% more likely to die of any cause over about a decade than those who consumed less than two servings per day.
Where’s the food?
There is very little actual food in UPF. “The NOVA classification provides 4 main classes of food and beverages, the last of which is represented by the ultraprocessed food group. This comprises products (e.g., snacks, drinks, and ready meals, ‘created mostly or entirely from substances extracted from foods or derived from food constituents with little, if any intact food, which often contain flavors, colors, and other additives that imitate or intensify the sensory qualities of foods or culinary preparations made from foods,’ ” Dr. Bonaccio and colleagues wrote.
Such foods are very convenient, tasty, inexpensive, and have a long shelf life. They are highly competitive with foods that are naturally ready to consume and freshly prepared dishes and meals, the authors add.
The researchers conducted a longitudinal analysis on 22,475 men and women (mean age, 55 years; range, 43-67 years) who were recruited from the Moli-sani Study, a population-based cohort of men and women aged 35 years and older in the Molise region of southern Italy, between 2005 and 2010. Participants were followed for 8.2 years.
Food intake was assessed with the Food Frequency Questionnaire; UPF was defined using the NOVA classification according to degree of processing.
UPF intakes were categorized as quartiles of the ratio of UPF to total food consumed.
Overall, study participants reported a median of 10% (interquartile range, 6.6%-14.6%) of dietary intake as UPF and a total of 181.5 g/d of UPF intake.
The foods that contributed most to total UPF consumed were processed meat, which accounted for 19.8% of UPF intake; pizza (16.8%); and cakes and pies (13.4%).
High consumers of UPF, defined as those for whom UPF constituted more than 14.6% of their total diet, were more likely to be women, to be younger, and to have a higher educational level. They also reported fewer risk factors and fewer baseline chronic diseases and health conditions than persons who consumed UPF less frequently.
In addition, high consumption of UPF was associated with lower adherence to the Mediterranean diet; higher intake of fat, sugar, dietary cholesterol, and sodium; and lower intake of fiber.
During a median follow-up of 8.2 years, 1,216 all-cause deaths occurred. Of these, 439 were attributed to CVD, 255 to IHD/cerebrovascular disease, 477 to cancer, and 300 to other causes.
The more UPF, the higher the risk for CVD, death
The researchers found a direct linear dose-response relation between a 5% increase in the proportion of UPF in the diet and risk for all-cause and CVD mortality.
Individuals who reported the highest intake of UPF (fourth quartile, 14.6% of total food) as opposed to the lowest (first quartile, UPF <6.6%) experienced increased risks for CVD mortality (hazard ratio, 1.58; 95% CI, 1.23-2.03), death from IHD/cerebrovascular disease (HR, 1.52, 95% CI, 1.10-2.09), and all-cause mortality (HR, 1.26; 95% CI, 1.09-1.46).
High sugar content accounted for 36.3% of the relation of UPF with IHD/cerebrovascular mortality. Other nutritional factors, such as saturated fats, were unlikely to play a role, the researchers wrote.
Biomarkers of renal function accounted for 20.1% of the association of UPF with all-cause mortality and 12.0% for that of UPF with CVD mortality.
Subgroup analyses indicated that the magnitude of the association between UPF and all-cause mortality risk was greater among high-risk individuals, such as those with a history of CVD or diabetes. UPF was also likely to be more strongly associated with CVD mortality among those high-risk groups.
The interesting finding that the association between UPF and CVD mortality was greater among individuals with good adherence to the Mediterranean diet, which is known to have health benefits, could be explained by the fact that people who may benefit from a Mediterranean diet are more susceptible to losing health advantages when they also include “detrimental dietary behavior,” whereas those who consume a poor-quality diet are less likely to be harmed by an additional unhealthy behavior such as eating UPF regularly, wrote Dr. Bonaccio and colleagues.
“This is an interesting study confirming that consumption of highly processed foods such as pizza, processed meats, and soda are associated with greater risks of cardiovascular disease,” Walter Willett, MD, professor of epidemiology and nutrition, Harvard School of Public Health, Boston, said in an interview.
“These higher risks appear to be mediated in part by high intakes of saturated fat and sugar, but lower intakes of health-promoting aspects of diet also likely contribute to the findings,” Dr. Willett said.
“Some processing of food can be useful for preservation and control of infectious agents, but in general, a diet emphasizing minimally processed fruits and vegetables, whole grains, nuts, legumes, and plant sources of fat will be best for long-term well-being,” he said.
The study was supported in part by the Italian Ministry of Health and the HYPERCAN Study Italian Association for Cancer Research. Dr. Bonaccio and Dr. Willett reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Bariatric surgery might reduce severity of COVID-19 infection
and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.
The research was published in Surgery for Obesity and Related Diseases.
Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.
They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.
Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.
“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
COVID-19 is a wake-up call for the consequences of obesity
Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”
More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”
Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.
Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.
Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.
Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
Small sample size, study should be repeated
For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.
Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.
The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.
The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.
The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).
Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.
Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.
Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
Continue as many aspects of obesity management as possible during pandemic
Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”
This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.
In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.
The research was published in Surgery for Obesity and Related Diseases.
Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.
They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.
Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.
“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
COVID-19 is a wake-up call for the consequences of obesity
Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”
More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”
Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.
Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.
Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.
Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
Small sample size, study should be repeated
For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.
Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.
The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.
The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.
The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).
Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.
Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.
Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
Continue as many aspects of obesity management as possible during pandemic
Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”
This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.
In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
and the disease was less severe than among COVID patients with obesity who had not undergone the surgery, a new retrospective analysis shows.
The research was published in Surgery for Obesity and Related Diseases.
Because obesity is a well-known risk factor for poor COVID-19 outcomes, Ali Aminian, MD, Bariatric and Metabolic Institute, Cleveland Clinic, and colleagues decided to study whether weight-loss surgery had a bearing on outcomes of patients with COVID-19.
They matched 33 COVID-19 patients who had undergone metabolic surgery with 330 control patients with obesity who were infected with the virus during the first wave of the pandemic.
Surgery was associated with a 69% reduction in the risk of being hospitalized as a result of COVID-19. None of the surgery patients required intensive care, mechanical ventilation, or dialysis, and none died.
“Patients after bariatric surgery become significantly healthier and can fight the virus better,” said Dr. Aminian in a statement from his institution. “If confirmed by future studies, this can be added to the long list of health benefits of bariatric surgery.”
COVID-19 is a wake-up call for the consequences of obesity
Dr. Aminian said in an interview that COVID-19 is a “wake-up call to show the public and health care professionals that obesity is a major health problem and has multiple health consequences.”
More than 300 articles in the literature show that obesity is a major risk factor for poor outcomes following COVID-19 infection. Dr. Aminian said the pandemic has “improved public awareness about the consequences of obesity.”
Compared with last year at his institution, the intake of new patients “who would like to join a program to have surgery or have some tools to help them to lose weight is almost double,” he noted.
Furthermore, referrals to their unit from primary care physicians, as well as from endocrinologists and cardiologists, for bariatric surgery nearly doubled in recent months.
Although the unit had to stop all bariatric surgeries for around 6 weeks in April because of COVID-19, it has performed the same number of procedures this year as in 2019 and 2018.
Because of the recent surge in COVID cases in Ohio, bariatric procedures are once again on hold. “Elective operations that require hospital beds after surgery have been paused to provide beds for patients who have COVID-19,” he explained.
Small sample size, study should be repeated
For their study, Dr. Aminian and colleagues examined the records of 4,365 patients at the Cleveland Clinic Health System who tested positive for the virus between March 8 and July 22, 2020.
Of these, 1,003 had a body mass index of at least 35 mg/kg2; 482 had a BMI of at least 40. The team identified 33 patients who had previously undergone metabolic surgery, comprising 20 sleeve gastrectomies and 13 Roux-en-Y gastric bypasses.
The surgical patients were propensity matched in a 1:10 ratio with nonsurgical control patients with a BMI of at least 40. The patients were matched on the basis of age, sex, ethnicity, location, smoking status, and history of chronic obstructive pulmonary disease.
The mean BMI of surgical patients was 49.1 before their procedure. It fell to 37.2 by the time they tested positive for COVID-19. This compares with an average of 46.7 in the control group at the time they tested positive for the virus.
The team found that 18.2% of metabolic surgery patients were admitted to hospital versus 42.1% of control patients (P = .013).
Moreover, metabolic surgery patients did not require admission to the intensive care unit, nor did they require mechanical ventilation or dialysis, and none died. This compares with 13.0% (P = .021), 6.7% (P = .24), 1.5%, and 2.4%, respectively, of patients in the control group.
Multivariate analysis indicated that prior metabolic surgery was associated with lower hospital admission, at an odds ratio of 0.31 (P = .028), in comparison with control patients with obesity.
Acknowledging the limited sample size of their study, the team wrote: “As this study reflects findings early in the course of the pandemic, it will be of interest to repeat this study with larger data sets and later in the course of the pandemic.”
Continue as many aspects of obesity management as possible during pandemic
Dr. Aminian underlined that, for him, the take-home message from the study is that health care professionals should “ideally” continue all aspects of obesity management during the pandemic, including “medical management, behavioral therapy, lifestyle changes, and access to bariatric surgery.”
This is despite the fact that insurance coverage for bariatric surgery has “always been a challenge for many patients, since many insurance plans do not cover” bariatric procedures, he noted.
In July, the American Society for Metabolic and Bariatric Surgery issued a statement declaring that obesity surgery should not be considered an elective procedure and should be resumed as soon as it’s safe to do so during any resurgence of the COVID-19 pandemic.
The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
New dietary guidelines omit recommended cuts to sugar, alcohol intake
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Teenage bone density declines following sleeve gastrectomy
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Adolescents who undergo sleeve gastrectomy have lower bone density and higher bone marrow fat at 1 year following surgery, new research shows.
“It’s almost paradoxical,” Miriam Bredella, MD, of Massachusetts General Hospital in Boston, told Medscape Medical News. “Despite marked loss of body fat, these children have more fat in their bones and decreased bone density.”
She explained that the dissected part of the stomach is filled with anabolic cells that are important for building bone mass. “When those cells are cut out, the body cannot produce the hormones for building up bone.” It’s a malabsorption problem, she added. “Cutting out parts of the stomach or gut leads to less absorption.”
It is well known that bariatric surgery in adults has long-term effects on bone, she said, but this is the first time it has been studied in children.
“Nobody thinks about bone loss in children, but it’s extremely important,” Bredella reports. “The adolescent years up to age 25 are when we accrue bone density, so if something happens during this critical time, it can lead to weak bones later in life.” In the case of these adolescents, peak bone mass is never reached.
To investigate the effects of sleeve gastrectomy on bone density and marrow adipose tissue in extremely obese teenagers, researchers at Massachusetts General Hospital and Harvard Medical School recruited 52 adolescents with a mean body mass index (BMI) of 45. They measured volumetric bone mineral density using quantitative computer tomography (QCT) of the lumbar spine.
“We used QCT instead of DEXA [dual energy x-ray absorptiometry] scan because it isn’t affected by changes in soft tissue; it’s less susceptible to extreme changes in body weight,” Bredella said. “With DEXA scan there are too many artifacts.”
Half of the group (n = 26) underwent surgery. At 1 year, those who underwent surgery lost an average of 34 kg (75 lb). Adolescents in the control group lost an average of 0.2 kg (0.5 lb) (P < .0001).
Both groups repeated the QCT scan at the 1-year follow-up. Researchers found a decrease in bone density in those who underwent sleeve gastrectomy vs. controls (P = .046).
In her presentation, Bredella showed the QCT of the L2 spine in a 17-year old female before surgery and 12 months later. Her volumetric bone mineral density decreased from 183 mg/cm3 to 146 mg/cm3.
“Sleeve gastrectomy in children is bad for bones,” Bradella said. “You have to take care of your bones. This is something people are not thinking about and it probably won’t be a problem when they’re young but will likely affect these patients with osteoporosis when they are older.”
Patients need to be aware of this, she warns, and take steps to combat the bone loss. “Drinking milk, taking vitamin D, and doing weight-bearing exercise may help increase the bone density,” she said.
The increased fat in the bone is also concerning, she said. “Increased fat in the bone is a phenomenon that we see in anorexic patients,” Bredella explained.
The body appears to store the fat in bone in case of need later on, she explained. “We know that in severe states of malnutrition the body has the ability to metabolize the fat in the bones.”
The obesity epidemic in America has given way to a 100-fold increase in sleeve gastrectomy procedures in teenagers between 2005 and 2014. “These patients need this surgery so they don›t die of cardiac arrest or diabetes,” she said. “But we need to make sure they get their bone mineral density checked frequently.”
“The results of this study are important,” Marc Michalsky, MD, Nationwide Children’s Hospital, Columbus, Ohio, told Medscape Medical News. “But they need to be put into context.”
“There is an impetus and argument to support bariatric surgery as it offers a significant reduction in BMI and an associated reversal and complete amelioration of obesity related diseases.”
What this study doesn’t address, he said, is whether this population will experience an increase in bone density-related fractures down the road.
“These results are a snapshot in time — a picture of one postoperative time point,” Michalsky pointed out. “Are we seeing a process that represents continued change in bone mineralization? It’s not unreasonable to assume that the radiological findings here may lead to real clinical impact, but we don’t know.”
Bredella and Michalsky have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
FDA approves liraglutide for adolescents with obesity
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
The Food and Drug Administration’s new indication for liraglutide (Saxenda) for weight loss in adolescents with obesity, announced on Dec. 4, received welcome as a milestone for advancing a field that’s seen no new drug options since 2003 and boosted by 50% the list of agents indicated for weight loss in this age group.
But liraglutide’s track record in adolescents in the key study published earlier in 2020 left some experts unconvinced that liraglutide’s modest effects would have much impact on blunting the expanding cohort of teens who are obese.
“Until now, we’ve had phentermine and orlistat with FDA approval” for adolescents with obesity, and phentermine’s label specifies only patients older than 16 years. “It’s important that the FDA deemed liraglutide’s benefits greater than its risks for adolescents,” said Aaron S. Kelly, PhD, leader of the 82-week, multicenter, randomized study of liraglutide in 251 adolescents with obesity that directly led to the FDA’s action.
“We have results from a strong, published randomized trial, and the green light from the FDA, and that should give clinicians reassurance and confidence to use liraglutide clinically,” said Dr. Kelly, professor of pediatrics and codirector of the Center for Pediatric Obesity Medicine at the University of Minnesota in Minneapolis.
An ‘unimpressive’ drop in BMI
Sonia Caprio, MD, had a more skeptical take on liraglutide’s role with its new indication: “Approval of higher-dose liraglutide is an improvement that reflects a willingness to accept adolescent obesity as a disease that needs treatment with pharmacological agents. However, the study, published in New England Journal of Medicine, was not impressive in terms of weight loss, and more importantly liraglutide was not associated with any significant changes in metabolic markers” such as insulin resistance, high-sensitivity C-reactive protein, lipoproteins and triglycerides, and hemoglobin A1c.
The observed average 5% drop in body mass index seen after a year on liraglutide treatment, compared with baseline and relative to no average change from baseline in the placebo arm, was “totally insufficient, and will not diminish any of the metabolic complications in youth with obesity,” commented Dr. Caprio, an endocrinologist and professor of pediatrics at Yale University in New Haven, Conn.
Results from the study led by Dr. Kelly also showed that liraglutide for 56 weeks cut BMI by 5% in 43% of patients, and by 10% in 26%, compared with respective rates of 19% and 8% among those in the placebo-control arm. He took a more expansive view of the potential benefits from weight loss of the caliber demonstrated by liraglutide in the study.
“In general, we wait too long with obesity in children; the earlier the intervention the better. A 3% or 4% reduction in BMI at 12 or 13 years old can pay big dividends down the road” when a typical adolescent trajectory of steadily rising weight can be flattened, he said in an interview.
Bariatric and metabolic surgery, although highly effective and usually safe, is seen by many clinicians, patients, and families as an “intervention of last resort,” and its very low level of uptake in adolescents bears witness to that reputation. It also creates an important niche for safe and effective drugs to fill as an adjunct to lifestyle changes, which are often ineffective when used by themselves. Liraglutide’s main mechanism for weight loss is depressing hunger, Dr. Kelly noted.
Existing meds have limitations
The existing medical treatments, orlistat and phentermine, both have significant drawbacks that limit their use. Orlistat (Xenical, Alli), FDA approved for adolescents 12-16 years old since 2003, limits intestinal fat absorption and as a result often produces unwanted GI effects. Phentermine’s approval for older adolescents dates from 1959 and has a weak evidence base, its label limits it to “short-term” use that’s generally taken to mean a maximum of 12 weeks. And, as a stimulant, phentermine has often been regarded as potentially dangerous, although Dr. Kelly noted that stimulants are well-accepted treatments for other disorders in children and adolescents.
“The earlier we treat obesity in youth, the better, given that it tends to track into adulthood,” agreed Dr. Caprio. “However, it remains to be seen whether weight reduction with a pharmacological agent is going to help prevent the intractable trajectories of weight and its complications. So far, it looks like surgery may be more efficacious,” she said in an interview.
Another drawback for the near future with liraglutide will likely be its cost for many patients, more than $10,000/year at full retail prices for the weight-loss formulation, given that insurers have had a poor record of covering the drug for this indication in adults, both Dr. Caprio and Dr. Kelly noted.
Compliance with liraglutide is also important. Dr. Kelly’s study followed patients for their first 26 weeks off treatment after 56 weeks on the drug, and showed that on average weights rebounded to virtually baseline levels by 6 months after treatment stopped.
Obesity treatment lasts a lifetime
“Obesity is a chronic disease, that requires chronic treatment, just like hypertension,” Dr. Kelly stressed, and cited the rebound seen in his study when liraglutide stopped as further proof of that concept. “All obesity treatment is lifelong,” he maintained.
He highlighted the importance of clinicians discussing with adolescent patients and their families the prospect of potentially remaining on liraglutide treatment for years to maintain weight loss. His experience with the randomized study convinced him that many adolescents with obesity are amenable to daily subcutaneous injection using the pen device that liraglutide comes in, but he acknowledged that some teens find this off-putting.
For the near term, Dr. Kelly foresaw liraglutide treatment of adolescents as something that will mostly be administered to patients who seek care at centers that specialize in obesity management. “I’ll think we’ll eventually see it move to more primary care settings, but that will be down the road.”
The study of liraglutide in adolescents was sponsored by Novo Nordisk, the company that markets liraglutide (Saxenda). Dr. Kelly has been a consultant to Novo Nordisk and also to Orexigen Therapeutics, Vivus, and WW, and he has received research funding from AstraZeneca. Dr. Caprio had no disclosures.
Endoscopic intragastric balloon improved NASH parameters
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Obesity a well-known risk factor for the development of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis, the latter of which is expected to become the leading indication for liver transplantation. As such addressing the steatosis in these patients is critical. A drop of even 5%-10% of total body weight with diet and exercise can result in significant improvement in liver disease.
In this article, Dr. Bazerbachi and colleagues work to advance the case for intragastric balloons as a successful treatment option for NAFLD. They performed a prospective, open-label study on 21 patients treated with an intragastric balloon for 6 months. Using gold-standard histology and noninvasive magnetic resonance elastography before and after therapy, they show significant improvement in NAFLD activity score (median change, 3 points; range, 1-4) over a short duration of treatment. Interestingly, the collection of the liver biopsy sample is done via endoscopic ultrasound, which can be easily performed during placement and removal of this intragastric balloon. While promising, follow-up studies are needed to show sustained improvement in NAFLD after the balloon is removed.
Wasif M. Abidi, MD, PhD, is assistant professor of medicine, gastroenterology, Baylor College of Medicine, Houston.
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
Endoscopically placed intragastric balloons were safe and effective for managing nonalcoholic fatty liver disease (NAFLD), according to the findings of an open-label, prospective study of 21 patients.
Six months after balloon placement, nonalcoholic fatty liver disease activity scores (NAS) had improved in 18 of 20 biopsied patients (90%), with a median decrease of 3 points (range, 1-4 points). Magnetic resonance elastography showed that fibrosis had improved by 1.5 stages in half of patients (10 of 20). “Other than postprocedural pain (in 5% of patients), no serious adverse events were reported,” Fateh Bazerbachi, MD, of Massachusetts General Hospital in Boston, and associates wrote in Clinical Gastroenterology and Hepatology.
Nonalcoholic fatty liver disease affects approximately 70% of obese adults and half of obese children, meaning that tens of millions of individuals are affected in the United States alone. Lifestyle changes rarely induce more than 10% body weight loss, the threshold for “meaningful improvement in NASH,” and bariatric surgery is not recommended for managing mild or moderate obesity and often is not desired by patients who do qualify, the researchers noted. “Endoscopic bariatric therapies are garnering more attention as potential strategies to address these shortcomings in obesity care and its comorbidities [, but] their influences on the driving and prognostic parameters of NAFLD remain unclear.”
In all, 81% of the study participants were women, with a mean age of 54 years and an average body mass index (BMI) of 44 kg/m2. At baseline, more than half had NAS scores of 4 or 5 and histologic fibrosis scores of 2 or 3. Baseline hemoglobin A1c levels averaged 7.4% (range, 5.1%-11.1%) and 29% of patients had impaired glucose tolerance. After receiving endoscopic ultrasound (EUS)–guided core liver biopsies, patients received an endoscopically placed fluid-filled intragastric balloon (Orbera, Apollo Endosurgery, Austin, Tex.). The balloon was removed 6 months later and magnetic resonance elastography and a second core biopsy were performed. One patient did not receive an exit biopsy (because of starting antithrombotic therapy) and thus was excluded from the final analysis.
Of 20 patients, 16 (80%) had at least a two-point improvement in NAS at 6 months, and half had NAS scores of less than 2, indicating remission of NASH. Three of 20 patients (15%) showed improvements in mild fibrosis, 12 showed no change, and 5 showed worsening. Patients lost an average of 11.7% of body weight (standard deviation, 7.7%; P = .01), BMI dropped by a mean of 5.2 (SD, 0.75; P = .01) and A1c fell by an average of 1.3% (SD, 0.5%; P = .02). Waist circumference also decreased significantly (mean, –14.4 cm; SD, –2.2 cm; P = .001), as did hip circumference, fasting glucose, AST, ALT, and AST-to-platelet ratio index. “Percent total body weight loss did not correlate with reductions in NAS or fibrosis,” the researchers noted.
Together, these findings suggest that intragastric balloon placement “may allow a reversal in the natural history of NAFLD and NASH, despite the short duration of the intervention,” they concluded. “The logistics of IGB [intragastric balloon] placement will enable accurate risk stratification of these patients in a safe and reproducible manner, obviating the need for additional investigations, and clarifying the real risk of patients afflicted with NAFLD.”
Apollo Endosurgery provided intragastric balloons, and Medtronic provided SharkCore needles. The senior author and two coinvestigators disclosed ties to Apollo Endosurgery, Medtronic, Metamodix, Boston Scientific, Cairn Diagnostics, Aspire Bariatrics, Johnson and Johnson, AstraZeneca, Genfit, Gila Therapeutics, and several other companies. The other investigators reported having no conflicts of interest.
SOURCE: Bazerbachi F et al. Clin Gastroenterol Hepatol. 2020 Apr 30. doi: 10.1016/j.cgh.2020.04.068.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Autologous fecal microbiota transplantation helped maintain weight loss after ‘green’ Mediterranean diet
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
In their recent publication in Gastroenterology, Rinott and Youngster et al. investigated whether autologous transplantation of diet-modified microbiota, delivered through oral capsules, prevented weight regain in abdominally obese individuals that were subjected to dietary regimens to induce weight loss. Transplantation of one’s own fecal microbiota collected after a calorie-restricted green Mediterranean diet (containing extra polyphenols) seemed to maintain metabolic improvements in comparison to placebo treatments during weight regain.
Nordin M.J. Hanssen, MD, is in the department of internal medicine, school for cardiovascular diseases, faculty of health, medicine and life sciences, Maastricht University, Amsterdam. He has no conflicts of interest relevant to this publication.
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
A high-polyphenol, calorie-restricted Mediterranean diet supplemented with green tea and the Mankai strain of duckweed optimized the microbiome for autologous fecal microbiota transplantation, which maintained both weight loss and insulin sensitivity after the diet ended, according to the findings of a novel clinical trial.
Eight months after the diet ended, 17% of individuals in the autologous fecal microbiota transplantation (aFMT) group had regained weight, compared with 50% of those who received oral placebo (P = .02). Gains in weight circumference were 1.89 cm and 5.05 cm, respectively (P = .01), and changes in fasting insulin levels were 1.46 (standard deviation, 3.6 mIU/mL) and 1.64 mIU/mL (standard deviation, 4.7 mIU/mL; P = .04). Notably, aFMT did not achieve these results after weight loss on a typical Mediterranean diet, with or without calorie restriction. “Diet-induced weight loss can be preserved, along with glycemic control, for months after a diet via aFMT capsules. A high-polyphenols, green plant-based or Mankai diet better optimizes the microbiome for an aFMT procedure,” Ehud Rinott, an MD, PhD student at Ben-Gurion University of the Negev in Beer-Sheva, Israel, and his associates wrote in Gastroenterology.
Significant weight regain after dieting is common and undermines cardiometabolic strides. In animal studies, FMT from lean to obese individuals induces both weight loss and metabolic improvements, and limited data point to similar benefits in humans. However, allogenic FMT in humans raises safety concerns and “practical barriers,” Mr. Rinott and his associates noted. Hypothesizing that aFMT of microbiota obtained at nadir weight might prevent postdiet rebounds, they randomly assigned 294 obese or dyslipidemic adults (average age, 52 years) to receive the calorie-restricted “green” Mediterranean diet or a standard Mediterranean diet with or without calorie restrictions for 6 months. At this time, microbiota obtained from fecal samples were frozen in colorless, odorless oral capsules that were considered indistinguishable from placebo capsules. Ninety participants who had lost at least 3.5% of their body weight (average loss, 8.3 kg) were then rerandomized in a double-blinded manner to receive once-daily aFMT or placebo capsules during months 8 through 14.
In all, 96% of participants consumed at least 80% of the capsules, a high rate of compliance. No adverse events from aFMT were reported. Metagenomic sequencing and 16s ribosomal RNA sequencing showed that only the “green” Mediterranean diet induced significant alterations in the gut microbiome during the weight-loss phase. In a complementary study of obese mice, autologous transplantation of microbiota obtained at nadir weight confirmed that adding Mankai during weight loss helped protect against subsequent regain and loss of insulin sensitivity.
All diets in this study emphasized vegetables while reducing sugars, salt, dietary cholesterol, trans and saturated fats, and poultry, and omitting processed and red meats. The “green” and standard calorie-restricted Mediterranean diets both limited calories to 1,500-1,800 per day for men and 1,200-1,400 per day for women (women comprised only 9% of study participants). In these two diets, fats – mainly monounsaturated and polyunsaturated – made up 40% of calories (including 28 g walnuts per day, containing 440 mg polyphenols), while carbohydrates were limited to less than 40 g per day in the first 2 months and then gradually increased to 80 g per day. The green Mediterranean diet added 3-4 cups of green tea daily and a shake containing 100 g of Mankai, which provided another 800 mg of polyphenols. All participants received free gym memberships and were told to exercise throughout the study (aerobic exercise for 45-60 minutes three to four times weekly, and resistance exercise two to three times weekly).
Funders included the Israeli Science Foundation, Israeli Ministry of Health, Israel Ministry of Science and Technology, German Research Foundation, California Walnuts Commission, and others. Mr. Rinott had no conflicts. Three coinvestigators disclosed ties to CoreBiome, Hinoman, and Mybiotics.
SOURCE: Rinott E et al. Gastroenterology. 2020 Aug 25. doi: 10.1053/j.gastro.2020.08.041.
FROM GASTROENTEROLOGY
FDA clears first drug for rare genetic causes of severe obesity
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration has approved setmelanotide (Imcivree, Rhythm Pharmaceuticals) for weight management in adults and children as young as 6 years with obesity because of proopiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing.
Individuals with these rare genetic causes of severe obesity have a normal weight at birth but develop persistent severe obesity within months because of insatiable hunger (hyperphagia).
Setmelanotide, a melanocortin-4 receptor (MC4R) agonist, is the first FDA-approved therapy for these disorders.
“Many patients and families who live with these diseases face an often-burdensome stigma associated with severe obesity. To manage this obesity and control disruptive food-seeking behavior, caregivers often lock cabinets and refrigerators and significantly limit social activities,” said Jennifer Miller, MD, a pediatric endocrinologist at University of Florida Health, Gainesville, in a press release issued by the company.
“This FDA approval marks an important turning point, providing a much needed therapy and supporting the use of genetic testing to identify and properly diagnose patients with these rare genetic diseases of obesity,” she noted.
David Meeker, MD, chair, president, and CEO of Rhythm Pharmaceuticals, added: “We are advancing a first-in-class, precision medicine that is designed to directly address the underlying cause of obesities driven by genetic deficits in the MC4R pathway.”
Setmelanotide was evaluated in two phase 3 clinical trials. In one trial, 80% of patients with obesity caused by POMC or PCSK1 deficiency achieved greater than 10% weight loss after 1 year of treatment.
In the other trial, 45.5% of patients with obesity caused by LEPR deficiency achieved greater than 10% weight loss with 1 year of treatment.
Results for the two trials were recently published in The Lancet Diabetes & Endocrinology and discussed at the ObesityWeek Interactive 2020 meeting.
Setmelanotide was generally well tolerated in both trials. The most common adverse events were injection-site reactions, skin hyperpigmentation, and nausea.
The drug label notes that disturbances in sexual arousal, depression, and suicidal ideation; skin pigmentation; and darkening of preexisting nevi may occur with setmelanotide treatment.
The drug label also notes a risk for serious adverse reactions because of benzyl alcohol preservative in neonates and low-birth-weight infants. Setmelanotide is not approved for use in neonates or infants.
The company expects the drug to be commercially available in the United States in the first quarter of 2021.
Setmelanotide for the treatment of obesity associated with rare genetic defects had FDA breakthrough therapy designation as well as orphan drug designation.
The company is also evaluating setmelanotide for reduction in hunger and body weight in a pivotal phase 3 trial in people living with Bardet-Biedl or Alström syndrome, and top-line data are due soon.
A version of this article originally appeared on Medscape.com.
Age no barrier to weight loss in those with morbid obesity
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Older adults should be recommended for hospital-based lifestyle interventions to reduce weight, say U.K. investigators after finding there was no difference in weight loss between older and younger individuals in their program for those with morbid obesity.
Thomas M. Barber, PhD, and colleagues looked back at nearly 250 randomly selected adults who attended their obesity service over an 11-year period.
Older individuals, defined as aged 60 years and over, had higher rates of type 2 diabetes but experienced a similar percentage weight loss and reduction in body mass index (BMI) as younger patients over the course of around 40 months.
“Age should be no barrier to lifestyle management of obesity,” said Dr. Barber, of University Hospitals Coventry (England) and Warwickshire, in a news release from his institution. “Rather than putting up barriers to older people accessing weight-loss programs, we should be proactively facilitating that process. To do otherwise would risk further and unnecessary neglect of older people through societal ageist misconceptions.”
He urged service providers and policy makers to “appreciate the importance of weight loss in older people with obesity for the maintenance of health and well-being and the facilitation of healthy aging. Furthermore, age per se should not contribute toward clinical decisions regarding the implementation of lifestyle management of older people.”
The research was published online Nov. 22 in Clinical Endocrinology.
Real-world data will inform clinical practice
Jason Halford, PhD, a professor of biological psychology and health behavior, said in an interview: “The fear is that older patients are perceived not to respond” to lifestyle interventions to control obesity, “and that’s clearly a fallacy, according to this study.”
The findings are strengthened by the fact that these are real-world data, “and so it will inform clinical practice,” he added.
And one of the “more interesting” findings was that [type 2] diabetes was “more prevalent” in the older group “but they’re still losing weight,” he noted.
“Traditionally it’s been thought that people with type 2 diabetes find it more difficult to lose weight because you’re trying to manage two conditions,” said Dr. Halford, of the University of Leeds (England), who is also president-elect of the European Association for the Study of Obesity.
Don’t discount older patients
The researchers note that many of the comorbidities associated with obesity “develop over time” and that “no one is immune to obesity,” regardless of their age, sex, ethnicity, and socioeconomic status.
Barber said there are “a number of reasons” why health care professionals “may discount weight loss in older people,” including “an ‘ageist’ perspective that weight-loss is not relevant to older people and misconceptions of reduced ability of older people to lose weight through dietary modification and increased exercise.”
And “older people may feel that hospital-based obesity services are not for them,” he noted.
To determine the effect of age on the ability to lose weight through lifestyle interventions, Dr. Barber and colleagues randomly selected 242 patients with morbid obesity who attended their hospital-based service between 2005 and 2016.
Of these, 167 were aged 18-60 years and 75 were aged 60 years and older. Most participants were women (75.4% of the younger patients and 60.0% of the older patients).
The proportion of patients with confirmed diabetes was markedly higher in the older group, compared with the younger group, at 62.7% versus 35.3%, although older patients had a significantly lower baseline BMI, at 46.9 versus 49.7 kg/m2 (P < .05).
The average duration of the lifestyle intervention was over 3 years (41.5 months) in the younger patients and 33.6 months in the older patients.
There was no significant difference in percentage weight loss between younger and older patients, at 6.9% and 7.3%, respectively, and no difference in percentage reduction in BMI, at 8.1% versus 7.8%.
Further analysis demonstrated that there was no significant correlation between age at referral to the hospital-based service and percentage weight loss (correlation coefficient, –0.13).
Dr. Halford said it would have been “useful” to know the proportion of patients achieving 5% and 10% weight loss because, if a third of patients lost more than 10% of their weight, “even in an elderly population, that would suggest there’d be real benefits in terms of things like type 2 diabetes,” he noted.
And he would like to have seen more data around how long participants had been struggling with obesity, as it’s “just an assumption that the second group is further down the path because they’re older, but we can’t be 100% sure.”
The team noted the study is limited by being retrospective and including a random selection of patients attending the service rather than the entire cohort.
Dr. Halford agreed but said the analysis is a “starting point” and could be used as a platform to conduct “much more systematic research on this area.”
No funding or relevant financial relationships were declared.
A version of this article originally appeared on Medscape.com.
Obesity phenotyping matches patients with more effective interventions
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
A phenotype-guided strategy for systematically matching weight-loss patients to their potentially ideal weight-loss drug roughly doubled treatment efficacy, compared with usual practice, in a single-center, randomized study with 268 patients.
In contrast, in 200 patients who received weight loss–drug therapy selected by routine means, 35% achieved greater than 10% loss compared with their starting weight, Andres J. Acosta, MD, said at the virtual ObesityWeek® Interactive 2020 meeting.
The phenotype-guided strategy also led to an average 16% weight loss from baseline after 12 months, compared with a 9% average loss among the usual-care controls, reported Dr. Acosta, a gastroenterologist at the Mayo Clinic in Rochester, Minn.
A “one-size-fits-all approach to weight loss treatment is not working,” he declared. “Our long-term goal is to develop a personalized approach to obesity management.”
Personalized weight loss treatment isn’t new
“The better we can match treatment to a patient’s needs, the more likely it will succeed. That’s not a brand new idea. They are trying to standardize the way that we classify the disorders that play a role in why a person gains weight or has trouble losing weight,” commented John D. Clark III, MD, an internal medicine physician and weight-management specialist at UT Southwestern Medical Center in Dallas.
The increased weight loss levels that Dr. Acosta reported in patients who underwent the study’s phenotyping protocol and received tailored treatment “are similar to the numbers we see when a patient’s treatment is the right fit for them. You see weight loss in these ranges,” Dr. Clark said in an interview.
The study run by Dr. Acosta and his associates consisted of two phases. First, they established normal and abnormal ranges for four different obesity phenotypes by studying 100 patients with obesity. The patients underwent an extensive and uniform workup designed to classify their obesity phenotype.
Four obesity phenotypes
The researchers categorized patients into one of four types:
- Disordered initial eating satiation, called ‘hungry brain,” and assessed by measuring food intake at a buffet, ad libidum meal.
- Disordered maintenance of satiety, called “hungry gut,” assessed by both a gastric-emptying study as well as patient self-assessment for postprandial fullness.
- “Emotional hunger,” assessed with two questionnaires.
- Disordered energy expenditure, called “slow burn,” assessed by measuring basal metabolic rate, and self-reports of both exercise and nonexercise activity.
Dr. Acosta estimated that the complete workup to assess all four potential phenotypes costs about $1,200.
The researchers then applied the 75th percentile value from each of these assessments to 450 patients with obesity in their clinic to see the prevalence of the four phenotypes. They identified a single phenotype in 58% of these patients, including 18% with hungry gut, 16% with hungry brain, 12% with emotional hunger, and 12% with slow burn. An additional 27% of the patients were positive for two or more phenotypes (including 9% who were positive for all four phenotypes), and 15% did not test positive for any of the four phenotypes.
Phenotype-guided treatments
They then applied their findings in a prospective randomized study that matched a drug intervention to each of the four phenotypes during a year-long, comprehensive weight-loss program at the Mayo Clinic’s Weight Management Clinic. The study randomized 100 patients to the phenotype-driven arm, with 68 of these patients receiving their assigned drug, and 200 patients served as controls. Patients averaged about 47 years old, and their average body mass index was about 41 kg/m2.
The investigational arm included 30 patients classified as having a hungry brain, with 20 of these patients treated with phentermine plus topiramate and 10 treated with lorcaserin (before it was withdrawn by the Food and Drug Administration); 12 with hungry gut and treated with liraglutide (Saxenda); 19 with emotional hunger who received naltrexone SR/bupropion SR (Contrave); and seven with slow burn who received phentermine.
The control arm included 200 patients seeking weight loss treatment at Mayo who did not undergo phenotyping and received their drug treatment based on their personal preference in consultation with their Mayo physician. In this group, drug treatment broke down as 106 patients (53%) on phentermine plus topiramate, 41 (21%) on liraglutide, 34 (17%) on phentermine alone, 14 (7%) on naltrexone SR/bupropion SR, and 5 patients (3%) on locaserin (percentages total 101% because of rounding).
Overall, phenotyping led to more patients treated with naltrexone SR/buproprion SR and lorcaserin and fewer treated with phentermine or phentermine and topiramate ER. All patients were eligible to also receive behavioral interventions as needed.
“We do a lot of testing to identify the phenotype,” in addition to gathering additional clues from a detailed history, said Dr. Acosta. Patients identified with more than one phenotype in routine practice at Mayo are often begun on more than one drug. When phenotyping fails to classify a patient, Dr. Acosta puts the patient on a low-calorie diet and then does a follow-up assessment “to see if the phenotype pops up as a metabolic adaptation.”
“This is something we’re all working toward” in the obesity management field. “How can we better identify the underlying causes in a way that can fit into the work flow. How can we move from research to things we can use daily in the clinic,” observed Dr. Clark. “We need a lot more investigation to determine how well this works in the real world. Are there other tools we can use that are not as expensive” as what Dr. Acosta used for this study?
“For this proof of concept study, it made sense to be very rigorous, but that probably is not realistic for every patient. What are other ways to get this information, or perhaps only use an extensive workup when initial weight loss attempts are unsuccessful,” Dr. Clark suggested.
FROM OBESITY WEEK 2020