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Adding Roux-en-Y gastric bypass surgery to lifestyle and medical management of type 2 diabetes provided significant benefits, but the effect diminished over time, according to findings published Jan. 16 in JAMA.

In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A_{1c (}HbA_1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .

At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.

The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA_1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m².

Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.

At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA_1c level of 9.6%, compared with a mean BMI of 34.9 and HbA_1c level of 9.6% in the gastric bypass group.

Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.

Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).

The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).

The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.

“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.

Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.

acssurgerynews@frontlinemedcom.com

SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.

Adding Roux-en-Y gastric bypass surgery to lifestyle and medical management of type 2 diabetes provided significant benefits, but the effect diminished over time, according to findings published Jan. 16 in JAMA.

In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A_{1c (}HbA_1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .

At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.

The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA_1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m².

Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.

At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA_1c level of 9.6%, compared with a mean BMI of 34.9 and HbA_1c level of 9.6% in the gastric bypass group.

Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.

Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).

The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).

The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.

“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.

Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.

acssurgerynews@frontlinemedcom.com

SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.

Adding Roux-en-Y gastric bypass surgery to lifestyle and medical management of type 2 diabetes provided significant benefits, but the effect diminished over time, according to findings published Jan. 16 in JAMA.

In a randomized study of 113 obese patients with diabetes, about 50% of those who received gastric bypass in addition to lifestyle and medical management achieved the composite endpoint of a hemoglobin A_{1c (}HbA_1c) value of less than 7%, an LDL cholesterol level of less than 100 mg/dL, and a systolic blood pressure of less than 130 mm Hg after 1 year, reported Sayeed Ikramuddin, MD, FACS, of the department of surgery at the University of Minnesota, Minneapolis, and his coauthors. For comparison, just 16% in the lifestyle/medical management group achieved the endpoint (difference, 34%; 95% confidence interval, 14%-54%; P = .003) .

At 5 years’ follow-up, about 23% of patients in the gastric bypass group and 4% in the lifestyle/medical management group achieved the composite triple endpoint (difference, 19%; 95% CI, 4%-34%; P = .01), the authors reported.

The study included 120 patients at four sites in the United States and Taiwan, 7 of whom either died or were lost to follow-up before completion of the study. Participants had an HbA_1c level of 8% or higher and a body mass index between 30 and 39.9 kg/m².

Patients were randomized to receive either 2 years of lifestyle and medical management alone or in conjunction with standardized Roux-en-Y gastric bypass. During the first 2 years of intervention, patients were told to record weight, exercise, and food intake and were prescribed 325 minutes of physical activity per week. Participants also met regularly with a trained interventionist and an endocrinologist and were given pharmacologic therapy for hyperglycemia, cholesterol, and hypertension, the authors said. Aside from usual visits with a primary physician, all study interventions ceased after the initial 2-year period.

At baseline, the group that received only lifestyle/medical management had a mean BMI of 34.4 and HbA_1c level of 9.6%, compared with a mean BMI of 34.9 and HbA_1c level of 9.6% in the gastric bypass group.

Primary endpoint success rates decreased in both groups between years 1 and 3, going from 50% to 23% in the gastric bypass group and from 16% to 4% in the lifestyle/medical management group, but it remained stable from year 3 through year 5, Dr. Ikramuddin and his coauthors said in the report.

Overall, 26% of patients who had gastric bypass surgery during the first year achieved the triple endpoint at 5 years, compared with 8% of those who did not have surgery (difference, 18%; 95% CI, 6%-32%; P = .04).

The mean weight loss for participants in the gastric bypass group was 21.8% at 5 years, compared with 9.6% in the lifestyle/medical management group (difference, 12.2%; 95% CI, 8.9%-15.5%).

The results suggest that “gastric bypass provides significant benefit but with a smaller and less durable effect size than what is seen in the evaluation of glycemic control alone,” the authors wrote.

“Because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement,” Dr. Ikramuddin and his colleagues concluded.

Dr. Ikramuddin disclosed relationships with Novo Nordisk, USGI Medical, Medica, Metamodix, Medtronic, ReShape Medical, and EnteroMedics.

acssurgerynews@frontlinemedcom.com

SOURCE: Ikramuddin S. JAMA. 2018;319(3):266-278.

Older Americans will now have access to insulin delivery devices under Part D of Medicare coverage, according to guidance issued by the Centers for Medicare & Medicaid Services (CMS). The CMS guidance clarified that devices not previously covered under Medicare Part B will be covered under Part D of the prescription drug program. As a result, older Americans will now have access to a wider range of insulin delivery devices.

Insulin delivery devices help patients manage blood sugar levels effectively. The devices prevent dangerous blood sugar fluctuations that can lead to complications like hypoglycemia.

In the guidance, the CMS wrote: “With the introduction of new insulin delivery devices to the market, questions have arisen about Part D coverage for these products. Specifically, we have been asked whether newer insulin delivery devices that are not covered under Medicare Part B meet the Part D definition of ‘medical supplies associated with the injection of insulin. … The examples that were previously provided were never intended to be an exhaustive list of products that could be covered under Part D. Instead, they represented our understanding of the types of medical supplies associated with the injection of insulin that were available at the time.”

Since then, new delivery devices have been introduced to market “in the form of both mechanical and electronic insulin pumps” that are not covered under the Medicare Part B durable medical equipment (DME) benefit.

“We expect that technology will continue to advance and that ‘medical supplies associated with the injection of insulin’ will become significantly more sophisticated,” wrote the CMS. “As new products become available, Part D sponsors may evaluate these products for formulary placement and medical necessity and, subject to Part D coverage determination and appeals requirements, allow access and restrict use accordingly.”

According to the guidance, Part D will cover supplies “that are alternatives to insulin syringes,” and the CMS will not require insurers who offer Part D plan coverage to include these on their formularies. If these alternatives are included on formularies, sponsors may use utilization management criteria for the products.

In a statement praising the CMS’s decision, the Endocrine Society wrote: “This opens the door for older Americans to gain coverage for devices such as the Omnipod insulin management system, a popular insulin pump system. Until the new guidance was issued, Omnipod was the only FDA [Food and Drug Administration]–approved insulin pump system not covered by Medicare. Previously, people with diabetes who qualified for Medicare at age 65 had to pay out of pocket to continue using the Omnipod, and many lost access to the device.”

Robert Lash, MD, chief professional and clinical affairs officer for the Endocrine Society, said in an interview that the new CMS guidance "gives physicians and people with diabetes access to a wider range of technology options, since some people with type 1 diabetes prefer the Omnipod’s tubing-free design because it makes it easier to participate in sports and safer to work in certain environments.

“Before this guidance was issued, those patients had to switch pumps or revert to insulin injections when they turned 65 years old. We are pleased this guidance will open the door to greater choice” for patients, said Dr. Lash.

The CMS’s decision on insulin delivery devices follows a decision last year to cover continuous glucose monitors (CGMs) through Medicare. Last week, the CMS also announced it will provide coverage for the Abbott Freestyle Libre CGM, a welcome move for patients seeking additional choices.

This article was revised 1/18/18.

Older Americans will now have access to insulin delivery devices under Part D of Medicare coverage, according to guidance issued by the Centers for Medicare & Medicaid Services (CMS). The CMS guidance clarified that devices not previously covered under Medicare Part B will be covered under Part D of the prescription drug program. As a result, older Americans will now have access to a wider range of insulin delivery devices.

Insulin delivery devices help patients manage blood sugar levels effectively. The devices prevent dangerous blood sugar fluctuations that can lead to complications like hypoglycemia.

In the guidance, the CMS wrote: “With the introduction of new insulin delivery devices to the market, questions have arisen about Part D coverage for these products. Specifically, we have been asked whether newer insulin delivery devices that are not covered under Medicare Part B meet the Part D definition of ‘medical supplies associated with the injection of insulin. … The examples that were previously provided were never intended to be an exhaustive list of products that could be covered under Part D. Instead, they represented our understanding of the types of medical supplies associated with the injection of insulin that were available at the time.”

Since then, new delivery devices have been introduced to market “in the form of both mechanical and electronic insulin pumps” that are not covered under the Medicare Part B durable medical equipment (DME) benefit.

“We expect that technology will continue to advance and that ‘medical supplies associated with the injection of insulin’ will become significantly more sophisticated,” wrote the CMS. “As new products become available, Part D sponsors may evaluate these products for formulary placement and medical necessity and, subject to Part D coverage determination and appeals requirements, allow access and restrict use accordingly.”

According to the guidance, Part D will cover supplies “that are alternatives to insulin syringes,” and the CMS will not require insurers who offer Part D plan coverage to include these on their formularies. If these alternatives are included on formularies, sponsors may use utilization management criteria for the products.

In a statement praising the CMS’s decision, the Endocrine Society wrote: “This opens the door for older Americans to gain coverage for devices such as the Omnipod insulin management system, a popular insulin pump system. Until the new guidance was issued, Omnipod was the only FDA [Food and Drug Administration]–approved insulin pump system not covered by Medicare. Previously, people with diabetes who qualified for Medicare at age 65 had to pay out of pocket to continue using the Omnipod, and many lost access to the device.”

Robert Lash, MD, chief professional and clinical affairs officer for the Endocrine Society, said in an interview that the new CMS guidance "gives physicians and people with diabetes access to a wider range of technology options, since some people with type 1 diabetes prefer the Omnipod’s tubing-free design because it makes it easier to participate in sports and safer to work in certain environments.

“Before this guidance was issued, those patients had to switch pumps or revert to insulin injections when they turned 65 years old. We are pleased this guidance will open the door to greater choice” for patients, said Dr. Lash.

The CMS’s decision on insulin delivery devices follows a decision last year to cover continuous glucose monitors (CGMs) through Medicare. Last week, the CMS also announced it will provide coverage for the Abbott Freestyle Libre CGM, a welcome move for patients seeking additional choices.

This article was revised 1/18/18.

Older Americans will now have access to insulin delivery devices under Part D of Medicare coverage, according to guidance issued by the Centers for Medicare & Medicaid Services (CMS). The CMS guidance clarified that devices not previously covered under Medicare Part B will be covered under Part D of the prescription drug program. As a result, older Americans will now have access to a wider range of insulin delivery devices.

Insulin delivery devices help patients manage blood sugar levels effectively. The devices prevent dangerous blood sugar fluctuations that can lead to complications like hypoglycemia.

In the guidance, the CMS wrote: “With the introduction of new insulin delivery devices to the market, questions have arisen about Part D coverage for these products. Specifically, we have been asked whether newer insulin delivery devices that are not covered under Medicare Part B meet the Part D definition of ‘medical supplies associated with the injection of insulin. … The examples that were previously provided were never intended to be an exhaustive list of products that could be covered under Part D. Instead, they represented our understanding of the types of medical supplies associated with the injection of insulin that were available at the time.”

Since then, new delivery devices have been introduced to market “in the form of both mechanical and electronic insulin pumps” that are not covered under the Medicare Part B durable medical equipment (DME) benefit.

“We expect that technology will continue to advance and that ‘medical supplies associated with the injection of insulin’ will become significantly more sophisticated,” wrote the CMS. “As new products become available, Part D sponsors may evaluate these products for formulary placement and medical necessity and, subject to Part D coverage determination and appeals requirements, allow access and restrict use accordingly.”

According to the guidance, Part D will cover supplies “that are alternatives to insulin syringes,” and the CMS will not require insurers who offer Part D plan coverage to include these on their formularies. If these alternatives are included on formularies, sponsors may use utilization management criteria for the products.

In a statement praising the CMS’s decision, the Endocrine Society wrote: “This opens the door for older Americans to gain coverage for devices such as the Omnipod insulin management system, a popular insulin pump system. Until the new guidance was issued, Omnipod was the only FDA [Food and Drug Administration]–approved insulin pump system not covered by Medicare. Previously, people with diabetes who qualified for Medicare at age 65 had to pay out of pocket to continue using the Omnipod, and many lost access to the device.”

Robert Lash, MD, chief professional and clinical affairs officer for the Endocrine Society, said in an interview that the new CMS guidance "gives physicians and people with diabetes access to a wider range of technology options, since some people with type 1 diabetes prefer the Omnipod’s tubing-free design because it makes it easier to participate in sports and safer to work in certain environments.

“Before this guidance was issued, those patients had to switch pumps or revert to insulin injections when they turned 65 years old. We are pleased this guidance will open the door to greater choice” for patients, said Dr. Lash.

The CMS’s decision on insulin delivery devices follows a decision last year to cover continuous glucose monitors (CGMs) through Medicare. Last week, the CMS also announced it will provide coverage for the Abbott Freestyle Libre CGM, a welcome move for patients seeking additional choices.

This article was revised 1/18/18.

Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.

In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.

copyright lokisurina/Thinkstock

SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.

Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.

In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.

copyright lokisurina/Thinkstock

SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.

Breastfeeding may reduce a woman’s risk of developing diabetes, with a prospective cohort study showing a strong, inverse association between lactation duration and risk of diabetes.

In a report published in the Jan. 16 online edition of JAMA Internal Medicine, researchers analyzed data from the Coronary Artery Risk Development Study in Young Adults (CARDIA), which followed 1,238 women aged 18-30 for 30 years, with multiple assessments of glucose tolerance over the course of the study.

copyright lokisurina/Thinkstock

SOURCE: JAMA Intern Med. 2016 Jan 16. doi: 10.1001/jamainternmed.2017.7978.

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

Bariatric surgery has been demonstrated to improve a host of obesity-related comorbidities, but the operation carries a risk of complications, including chronic abdominal pain and ulcers, that should acknowledged by clinicians and understood by patients, a large cohort study has shown.

Gunn Signe Jakobsen, MD, of Vestfold Hospital Trust, Tønsberg, Norway, and her colleagues wrote in an article published in JAMA, “Few studies report long-term complication rates. ... No large-scale clinical practice–based study has compared the long-term association of bariatric surgery and specialized medical obesity treatment with obesity-related somatic and mental comorbidities, nor the irrespective complication rates.”

The investigators compared outcomes from 932 patients who underwent bariatric surgery and 956 who underwent specialized medical treatment that involved either individual or group lifestyle intervention programs. The study population included 1,249 women and 639 men with an average age of 44 years and an average baseline body mass index of 44 kg/m².

The surgery patients were more likely than the medical treatment patients to have hypertension remission (absolute risk 32% vs. 12%, respectively), and less likely to develop new-onset hypertension (absolute risk 4% vs. 12%, respectively). Diabetes remission was significantly higher among surgery patients, compared with medical treatment patients (58% vs. 13%) as was the likelihood of dyslipidemia remission (43% vs. 13%). Surgery patients also were less likely to develop new-onset diabetes or dyslipidemia than the medical treatment patients.

However, more patients who underwent bariatric surgery had low ferritin levels, compared with the medical treatment patients (26% vs. 12%). The surgery patients were significantly more likely than the medical treatment patients to develop new-onset depression (adjusted relative risk, 1.5; 95% confidence interval, 1.4-1.7), anxiety and sleep disorders (aRR, 1.3; 95% CI, 1.2-1.5), and treatment with opioids (aRR, 1.3; 95% CI, 1.2-1.4). In addition, bariatric patients were more likely to have at least one additional gastrointestinal surgical procedure (aRR, 2.0; 95% CI, 1.7-2.4), an operation for intestinal obstruction (aRR, 10.5; 95% CI, 5.1-21.5), abdominal pain (aRR, 1.9; 95% CI, 1.6-2.3), and gastroduodenal ulcers (aRR, 3.4; 95% CI 2.0-5.6).

The study was limited by several factors, including selection bias of younger, heavier patients in the bariatric surgery group, the lack of data on actual weight loss, incomplete laboratory data, and a relatively homogeneous white population, the researchers noted. However, the nearly 100% follow-up over approximately 6 years adds to the strength of the findings, which suggest that “the risk for complications should be considered in the decision-making process,” for obese patients considering bariatric surgery, they said.

Dr. Jakobsen was supported by the Vestfold Hospital Trust, with no financial conflicts to disclose.

SOURCE: Jakobsen G et al. JAMA. 2018 Jan 16;319(3):291-301.

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

LOS ANGELES – Current and previous night workers had significantly increased levels of hemoglobin A_1c, compared with diurnal workers, preliminary results from an ongoing study showed. The finding sheds further insight into the link between environmental light, circadian rhythms, and metabolic disorders.

“To date, observational studies on bright light have revealed that evening bright light is associated with increased appetite and that bedroom light intensity is correlated with obesity,” Massimo Federici, MD, said at the World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease. “It’s also been reported that artificial light is correlated with type 2 diabetes in the home setting and that daytime light exposure is positively correlated with body mass index. However, no studies have directly investigated the effect of acute light on human glucose metabolism.”

Doug Brunk/Frontline Medical News

dbrunk@frontlinemedcom.com

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

aotto@frontlinemedcom.com

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

aotto@frontlinemedcom.com

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

SAN DIEGO – When researchers at the University of Nebraska placed sensors in the cars of patients with type 1 diabetes, they found something interesting: About 3.4% of the time, the patients were driving with a blood glucose below 70 mg/dL.

Almost 10% of the time, it was above 300 mg/dL, and both hyper and hypoglycemia, but especially hypoglycemia, corresponded with erratic driving, especially at highway speeds.

The finding explains why patients taking insulin for type 1 diabetes have a 12%-19% higher risk of crashing their cars, compared with the general population. But in a larger sense, the study speaks to a new possibility as cars become smarter: monitoring drivers’ mental states and pulling over to the side of the road or otherwise taking control if there’s a problem.

The “results show that vehicle sensor and physiologic data can be successfully linked to quantify individual driver performance and behavior in drivers with metabolic disorders that affect brain function. The work we are doing could be used to tune the algorithm that drive these automated vehicles. I think this is a very important area of study,” said senior investigator Matthew Rizzo, MD, chair of the university’s department of neurological sciences in Omaha.

aotto@frontlinemedcom.com

SOURCE: Rizzo M, et al., ANA 2017 abstract number S131

The Food and Drug Administration has approved Sanofi’s insulin lispro injections (Admelog) for improved blood sugar control in adults and children aged 3 years and older with type 1 and type 2 diabetes mellitus, according to a news release from the FDA.

Insulin lispro injections are to be administered subcutaneously by injection, infusion via an insulin pump, or intravenously. Doses should be individualized based on route of administration and patients’ individual metabolic needs. All diabetes patients should regularly monitor their blood sugar levels and insulin regimens should be exclusively modified under medical supervision.

“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” Mary T. Thanh Hai, MD, deputy director of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Admelog, a biosimilar to Eli Lilly’s Humalog, was approved as a follow-on product based on the prior approval of Humalog. This allowed insulin lispro injections to be passed through the abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, formally known as the 505(b)(2) pathway. The makers of insulin lispro found it was scientifically justified to use the previous safety and effectiveness data from the approval of Humalog to support the approval of insulin lispro injections. In addition to the Humalog data, the insulin lispro injection data included findings from two phase 3 clinical trials, each of which comprised about 500 diabetes patients. Using this abbreviated pathway can reduce the costs of drug development significantly, allowing new products to be offered to patients at lower prices.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” FDA Commissioner Scott Gottlieb, MD, said in a statement “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”

Insulin lispro injections are short-acting insulin products that can help improve blood sugar levels in diabetes patients. This can be useful in controlling blood sugar levels after eating. This contrasts with long-acting insulin products, which are intended to control background insulin levels between meals. The blood sugar control needs of type 1 and type 2 diabetes patients are unique. Type 1 patients require both short- and long-term controls, while some type 2 patients may never need a short-acting insulin product. Because of these differences, providing insulin lispro injections as a blood sugar control method may be particularly useful to type 1 diabetes patients who need to control mealtime blood sugar levels.

ilacy@frontlinemedcom.com

The Food and Drug Administration has approved Sanofi’s insulin lispro injections (Admelog) for improved blood sugar control in adults and children aged 3 years and older with type 1 and type 2 diabetes mellitus, according to a news release from the FDA.

Insulin lispro injections are to be administered subcutaneously by injection, infusion via an insulin pump, or intravenously. Doses should be individualized based on route of administration and patients’ individual metabolic needs. All diabetes patients should regularly monitor their blood sugar levels and insulin regimens should be exclusively modified under medical supervision.

“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” Mary T. Thanh Hai, MD, deputy director of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Admelog, a biosimilar to Eli Lilly’s Humalog, was approved as a follow-on product based on the prior approval of Humalog. This allowed insulin lispro injections to be passed through the abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, formally known as the 505(b)(2) pathway. The makers of insulin lispro found it was scientifically justified to use the previous safety and effectiveness data from the approval of Humalog to support the approval of insulin lispro injections. In addition to the Humalog data, the insulin lispro injection data included findings from two phase 3 clinical trials, each of which comprised about 500 diabetes patients. Using this abbreviated pathway can reduce the costs of drug development significantly, allowing new products to be offered to patients at lower prices.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” FDA Commissioner Scott Gottlieb, MD, said in a statement “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”

Insulin lispro injections are short-acting insulin products that can help improve blood sugar levels in diabetes patients. This can be useful in controlling blood sugar levels after eating. This contrasts with long-acting insulin products, which are intended to control background insulin levels between meals. The blood sugar control needs of type 1 and type 2 diabetes patients are unique. Type 1 patients require both short- and long-term controls, while some type 2 patients may never need a short-acting insulin product. Because of these differences, providing insulin lispro injections as a blood sugar control method may be particularly useful to type 1 diabetes patients who need to control mealtime blood sugar levels.

ilacy@frontlinemedcom.com

The Food and Drug Administration has approved Sanofi’s insulin lispro injections (Admelog) for improved blood sugar control in adults and children aged 3 years and older with type 1 and type 2 diabetes mellitus, according to a news release from the FDA.

Insulin lispro injections are to be administered subcutaneously by injection, infusion via an insulin pump, or intravenously. Doses should be individualized based on route of administration and patients’ individual metabolic needs. All diabetes patients should regularly monitor their blood sugar levels and insulin regimens should be exclusively modified under medical supervision.

“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” Mary T. Thanh Hai, MD, deputy director of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Admelog, a biosimilar to Eli Lilly’s Humalog, was approved as a follow-on product based on the prior approval of Humalog. This allowed insulin lispro injections to be passed through the abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, formally known as the 505(b)(2) pathway. The makers of insulin lispro found it was scientifically justified to use the previous safety and effectiveness data from the approval of Humalog to support the approval of insulin lispro injections. In addition to the Humalog data, the insulin lispro injection data included findings from two phase 3 clinical trials, each of which comprised about 500 diabetes patients. Using this abbreviated pathway can reduce the costs of drug development significantly, allowing new products to be offered to patients at lower prices.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” FDA Commissioner Scott Gottlieb, MD, said in a statement “In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”

Insulin lispro injections are short-acting insulin products that can help improve blood sugar levels in diabetes patients. This can be useful in controlling blood sugar levels after eating. This contrasts with long-acting insulin products, which are intended to control background insulin levels between meals. The blood sugar control needs of type 1 and type 2 diabetes patients are unique. Type 1 patients require both short- and long-term controls, while some type 2 patients may never need a short-acting insulin product. Because of these differences, providing insulin lispro injections as a blood sugar control method may be particularly useful to type 1 diabetes patients who need to control mealtime blood sugar levels.

ilacy@frontlinemedcom.com

Type 2 diabetes mellitus remitted without medication in 46% of subjects who followed a strict, calorie-controlled diet for 1 year, judging from the findings of an open-label, cluster-randomized trial.

Remission rates closely tracked weight loss, Michael E.J. Lean, MD, reported in the Dec. 5 online issue of the Lancet. Among those who lost 15 kg or more, 86% also normalized their hemoglobin A1c levels. Lesser weight losses were successful too, with diabetes remitting in 57% of those who lost 10-15 kg and 34% of those who lost 5-10 kg, reported Dr. Lean, who is chair of human nutrition at the University of Glasgow.

Weight loss conferred other benefits as well. Quality of life improved significantly, triglycerides declined, and about half of the subjects were able to discontinue both their antidiabetic and antihypertension prescriptions.

DiRECT (the Diabetes Remission Clinical Trial) didn’t include a strict exercise component – something that sets it apart from most dietary interventions, Dr. Lean noted in a press statement. Instead, the study’s “Counterweight-plus” diet intervention focused on very strict calorie control. Counterweight is a proprietary, subscription-based weight-loss program that costs about $570 for 1 year.

The paper offered few details about the intervention, which was supervised by a nurse and/or dietitian. For the first 3-5 months, patients consumed only Counterweight-branded soups and shakes, amounting to about 850 calories per day. After that, solid foods were reintroduced over 2-8 weeks. There was ongoing support for weight-loss maintenance, including cognitive-behavioral therapy, combined with strategies to increase physical activity. Activity strategies were confined to encouraging subjects to walk up to 15,000 steps per day in the second and third phase, but the investigators had little hope that this would actually occur.

“It was recognized that this target was unlikely to be achieved by many, and objectively measured physical activity showed no increase in physical activity in either group between baseline and 12 months, which underlines the difficulty this population has in maintaining increased activity,” they noted.

DiRECT enrolled 298 adults with type 2 diabetes recruited from 49 primary care practices across Scotland and England. They were about 54 years old, with a mean diabetes duration of about 3 years. Subjects were assigned to either the Counterweight-plus weight management program or best practice care under current guidelines. At baseline, subjects’ mean body mass index was 35 mg/m². Their mean HbA_1c was about 7.6%; about 75% were taking at least one antidiabetic medication, and 30% taking two or more. Hypertension was present in more than half.

In the active group, investigators withdrew all antidiabetic and antihypertensive medications when the diet commenced. Antihypertensives were restarted only if subjects experienced an increase in systolic blood pressure. Patients in the control group stayed on their medications.

At 12 months, the mean weight loss was significantly greater in the intervention group than the control group (10 kg vs. 1 kg). Weight loss of at least 15 kg occurred in 24% of the intervention group and none of the control group. It was most pronounced in the total diet replacement phase, falling by a mean of 14.5 kg; participants regained weigh during the food reintroduction phase (mean, 1 kg) and again during the maintenance phase (mean, 1.9 kg). Four subjects in the intervention group who experienced diabetes remission needed a “short rescue plan” on the total diet replacement phase because of weight regain within 60 days of the study’s end. The authors didn’t say how much weight these patients regained.

By the end of the study period, diabetes had remitted in 46% of the intervention group and 4% of the control group (odds ratio, 19.7) and was positively associated with the amount of weight loss.

At 12 months, 74% of the intervention group and 18% of the control group were off antidiabetic medications. HbA_1c was significantly better in the intervention group (mean 6.4% vs. 7.2%). Antihypertensive drugs also were less common among the intervention group (32% vs. 61%) at 12 months. Despite the reduction in medication, there were no significant changes in blood pressure from baseline.

Nine serious adverse events occurred among seven intervention subjects. Two (biliary colic and abdominal pain) occurred in the same subject and were considered related to the diet, but they did not withdraw promptly.

Counterweight sponsored the trial, and several of the coinvestigators are stockholders and were company employees during the study. Dr. Lean reported financial remuneration from Counterweight.

msullivan@frontlinemedcom.com

SOURCE: Lean M et al. Lancet 2017 Dec 5; doi: 10.1016/ S0140-6736(17)33102-1.

Type 2 diabetes mellitus remitted without medication in 46% of subjects who followed a strict, calorie-controlled diet for 1 year, judging from the findings of an open-label, cluster-randomized trial.

Remission rates closely tracked weight loss, Michael E.J. Lean, MD, reported in the Dec. 5 online issue of the Lancet. Among those who lost 15 kg or more, 86% also normalized their hemoglobin A1c levels. Lesser weight losses were successful too, with diabetes remitting in 57% of those who lost 10-15 kg and 34% of those who lost 5-10 kg, reported Dr. Lean, who is chair of human nutrition at the University of Glasgow.

Weight loss conferred other benefits as well. Quality of life improved significantly, triglycerides declined, and about half of the subjects were able to discontinue both their antidiabetic and antihypertension prescriptions.

DiRECT (the Diabetes Remission Clinical Trial) didn’t include a strict exercise component – something that sets it apart from most dietary interventions, Dr. Lean noted in a press statement. Instead, the study’s “Counterweight-plus” diet intervention focused on very strict calorie control. Counterweight is a proprietary, subscription-based weight-loss program that costs about $570 for 1 year.

The paper offered few details about the intervention, which was supervised by a nurse and/or dietitian. For the first 3-5 months, patients consumed only Counterweight-branded soups and shakes, amounting to about 850 calories per day. After that, solid foods were reintroduced over 2-8 weeks. There was ongoing support for weight-loss maintenance, including cognitive-behavioral therapy, combined with strategies to increase physical activity. Activity strategies were confined to encouraging subjects to walk up to 15,000 steps per day in the second and third phase, but the investigators had little hope that this would actually occur.

“It was recognized that this target was unlikely to be achieved by many, and objectively measured physical activity showed no increase in physical activity in either group between baseline and 12 months, which underlines the difficulty this population has in maintaining increased activity,” they noted.

DiRECT enrolled 298 adults with type 2 diabetes recruited from 49 primary care practices across Scotland and England. They were about 54 years old, with a mean diabetes duration of about 3 years. Subjects were assigned to either the Counterweight-plus weight management program or best practice care under current guidelines. At baseline, subjects’ mean body mass index was 35 mg/m². Their mean HbA_1c was about 7.6%; about 75% were taking at least one antidiabetic medication, and 30% taking two or more. Hypertension was present in more than half.

In the active group, investigators withdrew all antidiabetic and antihypertensive medications when the diet commenced. Antihypertensives were restarted only if subjects experienced an increase in systolic blood pressure. Patients in the control group stayed on their medications.

At 12 months, the mean weight loss was significantly greater in the intervention group than the control group (10 kg vs. 1 kg). Weight loss of at least 15 kg occurred in 24% of the intervention group and none of the control group. It was most pronounced in the total diet replacement phase, falling by a mean of 14.5 kg; participants regained weigh during the food reintroduction phase (mean, 1 kg) and again during the maintenance phase (mean, 1.9 kg). Four subjects in the intervention group who experienced diabetes remission needed a “short rescue plan” on the total diet replacement phase because of weight regain within 60 days of the study’s end. The authors didn’t say how much weight these patients regained.

By the end of the study period, diabetes had remitted in 46% of the intervention group and 4% of the control group (odds ratio, 19.7) and was positively associated with the amount of weight loss.

At 12 months, 74% of the intervention group and 18% of the control group were off antidiabetic medications. HbA_1c was significantly better in the intervention group (mean 6.4% vs. 7.2%). Antihypertensive drugs also were less common among the intervention group (32% vs. 61%) at 12 months. Despite the reduction in medication, there were no significant changes in blood pressure from baseline.

Nine serious adverse events occurred among seven intervention subjects. Two (biliary colic and abdominal pain) occurred in the same subject and were considered related to the diet, but they did not withdraw promptly.

Counterweight sponsored the trial, and several of the coinvestigators are stockholders and were company employees during the study. Dr. Lean reported financial remuneration from Counterweight.

msullivan@frontlinemedcom.com

SOURCE: Lean M et al. Lancet 2017 Dec 5; doi: 10.1016/ S0140-6736(17)33102-1.

Type 2 diabetes mellitus remitted without medication in 46% of subjects who followed a strict, calorie-controlled diet for 1 year, judging from the findings of an open-label, cluster-randomized trial.

Remission rates closely tracked weight loss, Michael E.J. Lean, MD, reported in the Dec. 5 online issue of the Lancet. Among those who lost 15 kg or more, 86% also normalized their hemoglobin A1c levels. Lesser weight losses were successful too, with diabetes remitting in 57% of those who lost 10-15 kg and 34% of those who lost 5-10 kg, reported Dr. Lean, who is chair of human nutrition at the University of Glasgow.

Weight loss conferred other benefits as well. Quality of life improved significantly, triglycerides declined, and about half of the subjects were able to discontinue both their antidiabetic and antihypertension prescriptions.

DiRECT (the Diabetes Remission Clinical Trial) didn’t include a strict exercise component – something that sets it apart from most dietary interventions, Dr. Lean noted in a press statement. Instead, the study’s “Counterweight-plus” diet intervention focused on very strict calorie control. Counterweight is a proprietary, subscription-based weight-loss program that costs about $570 for 1 year.

The paper offered few details about the intervention, which was supervised by a nurse and/or dietitian. For the first 3-5 months, patients consumed only Counterweight-branded soups and shakes, amounting to about 850 calories per day. After that, solid foods were reintroduced over 2-8 weeks. There was ongoing support for weight-loss maintenance, including cognitive-behavioral therapy, combined with strategies to increase physical activity. Activity strategies were confined to encouraging subjects to walk up to 15,000 steps per day in the second and third phase, but the investigators had little hope that this would actually occur.

“It was recognized that this target was unlikely to be achieved by many, and objectively measured physical activity showed no increase in physical activity in either group between baseline and 12 months, which underlines the difficulty this population has in maintaining increased activity,” they noted.

DiRECT enrolled 298 adults with type 2 diabetes recruited from 49 primary care practices across Scotland and England. They were about 54 years old, with a mean diabetes duration of about 3 years. Subjects were assigned to either the Counterweight-plus weight management program or best practice care under current guidelines. At baseline, subjects’ mean body mass index was 35 mg/m². Their mean HbA_1c was about 7.6%; about 75% were taking at least one antidiabetic medication, and 30% taking two or more. Hypertension was present in more than half.

In the active group, investigators withdrew all antidiabetic and antihypertensive medications when the diet commenced. Antihypertensives were restarted only if subjects experienced an increase in systolic blood pressure. Patients in the control group stayed on their medications.

At 12 months, the mean weight loss was significantly greater in the intervention group than the control group (10 kg vs. 1 kg). Weight loss of at least 15 kg occurred in 24% of the intervention group and none of the control group. It was most pronounced in the total diet replacement phase, falling by a mean of 14.5 kg; participants regained weigh during the food reintroduction phase (mean, 1 kg) and again during the maintenance phase (mean, 1.9 kg). Four subjects in the intervention group who experienced diabetes remission needed a “short rescue plan” on the total diet replacement phase because of weight regain within 60 days of the study’s end. The authors didn’t say how much weight these patients regained.

By the end of the study period, diabetes had remitted in 46% of the intervention group and 4% of the control group (odds ratio, 19.7) and was positively associated with the amount of weight loss.

At 12 months, 74% of the intervention group and 18% of the control group were off antidiabetic medications. HbA_1c was significantly better in the intervention group (mean 6.4% vs. 7.2%). Antihypertensive drugs also were less common among the intervention group (32% vs. 61%) at 12 months. Despite the reduction in medication, there were no significant changes in blood pressure from baseline.

Nine serious adverse events occurred among seven intervention subjects. Two (biliary colic and abdominal pain) occurred in the same subject and were considered related to the diet, but they did not withdraw promptly.

Counterweight sponsored the trial, and several of the coinvestigators are stockholders and were company employees during the study. Dr. Lean reported financial remuneration from Counterweight.

msullivan@frontlinemedcom.com

SOURCE: Lean M et al. Lancet 2017 Dec 5; doi: 10.1016/ S0140-6736(17)33102-1.

Among rural adults, multiple chronic health conditions are most common in non-Hispanic blacks and American Indians/Alaska Natives (AI/ANs) and least common among Asians and Native Hawaiians/other Pacific Islanders (NHOPIs), according to the Centers for Disease Control and Prevention.

rfranki@frontlinemedcom.com

Among rural adults, multiple chronic health conditions are most common in non-Hispanic blacks and American Indians/Alaska Natives (AI/ANs) and least common among Asians and Native Hawaiians/other Pacific Islanders (NHOPIs), according to the Centers for Disease Control and Prevention.

rfranki@frontlinemedcom.com

Among rural adults, multiple chronic health conditions are most common in non-Hispanic blacks and American Indians/Alaska Natives (AI/ANs) and least common among Asians and Native Hawaiians/other Pacific Islanders (NHOPIs), according to the Centers for Disease Control and Prevention.

rfranki@frontlinemedcom.com

ORLANDO – Bariatric surgery significantly linked with increased levels of alcohol use and abuse in a meta-analysis of 28 studies with a total of nearly 16,000 patients.

Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.

Mitchel L. Zoler/Frontline Medical News

mzoler@frontlinemedcom.com

SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.
 

ORLANDO – Bariatric surgery significantly linked with increased levels of alcohol use and abuse in a meta-analysis of 28 studies with a total of nearly 16,000 patients.

Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.

Mitchel L. Zoler/Frontline Medical News

mzoler@frontlinemedcom.com

SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.
 

ORLANDO – Bariatric surgery significantly linked with increased levels of alcohol use and abuse in a meta-analysis of 28 studies with a total of nearly 16,000 patients.

Following any of several methods of bariatric surgery, patients showed a statistically significant 8% higher rate of new onset alcohol abuse, and a relative 50% increased rate of significant alcohol use, compared with rates before surgery, Prandeet Wander, MD, said at the World Congress of Gastroenterology at ACG 2017.

Mitchel L. Zoler/Frontline Medical News

mzoler@frontlinemedcom.com

SOURCE: Wander P et al. World Congress of Gastroenterology, abstract 10.