Diabetes remission more likely with RYGB than intervention

NEW ORLEANS — Over 2 years, Roux-en-Y gastric bypass was associated with greater benefits in diabetes remission and improvement of cardiovascular risk factors compared with optimal medical and lifestyle management in Asian Indian adults, according to results of the COSMID trial.

COSMID is a prospective, randomized, parallel-group, single-center clinical trial. Shashank S. Shah, MBBS, MS, MS, FAIS, FICS, director of the Laparo-Obeso Centre in Pune, India, and colleagues evaluated 80 patients with uncontrolled type 2 diabetes and BMI of 25 to 40 kg/m² (mean, 31.3 kg/m²) were randomly assigned to undergo Roux-en-Y gastric bypass (RYGB) or receive optimal medical and lifestyle intervention. Mean diabetes duration was 8.3 years.

Participants were studied every 3 months for up to 2 years. Thirty-four participants completed 2 years of follow-up. Researchers measured glycemic status, metabolic profiles, medication use, body composition, IV glucose tolerance tests, meal tests, microvascular complications and quality of life.

At baseline, participants assigned RYGB or medical and lifestyle management were similar for age, sex, diabetes duration, HbA1c, fasting insulin and glucose, insulin use, BMI, waist circumference, body composition, blood pressure and lipids.

According to data presented at the American Diabetes Association Scientific Sessions, maximum weight loss was greater with RYGB compared with medical and lifestyle intervention (25.9% vs. 4.4%; P < .0001). The RYGB group lost more body fat and lean mass compared with the intervention group. There were no differences in bone mineral content between RYGB or intervention.

At 2-year follow-up, participants who underwent RYGB had greater rates of type 2 diabetes remission (60% vs. 2.5%; P < .0001), glycemic control (81% vs. 30%; P < .0001) and diabetes improvement (100% vs. 73%; P = .003), and greater reductions in HbA1c (mean reduction, 9.3% to 6.4% vs. 9.5% vs. 8.2%; P < .0001) compared with the intervention group. Fasting insulin was 5.2 times lower (P < .001) and diabetes medication use was cut in half at 2 years in the RYGB group (P < .001). BP was lowered over 2 years in both groups, but reductions were greater after RYGB (P < .001 for systolic and diastolic BP).

“Gastric bypass and metabolic surgery offers an effective treatment option, more so than lifestyle intervention, and resulted in greater improvements in glycemic control, type 2 diabetes and HbA1c,” Shah said during his presentation.

COSMID is the first randomized controlled study that specifically addresses the Asian Indian population. Asian Indians have a strong ethnic and genetic predisposition for developing diabetes at a younger age and at a lower BMI compared with white adults. At the same weight as a white adult, an Asian Indian adult has greater risk for obesity related conditions such as CV disease and diabetes.

This trial “provides evidence that gastric bypass is a superior treatment to medical management alone, and should be an option for patients who qualify,” Shah said in a press release. – by Amber Cox

Reference:

Shah SS, et al. 261-OR. Presented at: American Diabetes Association Scientific Sessions; June 10-14, 2016; New Orleans.

Disclosure: The study was funded by Ethicon. Shah reports no relevant financial disclosures.