IMPORTANCE
Address unanswered questions about the role of bariatric surgery for people with diabetes.
OBJECTIVE
Determine feasibility of a randomized controlled trial (RCT) and compare initial outcomes of bariatric surgery and a structured weight loss program for treating type 2 diabetes mellitus in grade 1 and 2 obese participants.
DESIGN, SETTING, PARTICIPANTS
A 12-month, 3-arm RCT at a single center including 69 participants age 25–55 years, BMI 30–40 with type 2 diabetes.
INTERVENTIONS
Two surgical procedures; Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric band (LAGB) and an intensive lifestyle weight loss intervention (LWLI).
MAIN OUTCOMES AND MEASURES
Primary outcomes in the intention to treat (ITT) cohort were feasibility and effectiveness measured by weight loss and improvements in glycemic control.
RESULTS
667 potential participants were screened of whom 69 (10.3%) were randomized, 30 (43.5%) with grade 1 obesity. Mean age was 47.3±6.4 years, 81% were women, and mean glycated hemoglobin was 7.9±2.0. After randomization, 7 (10%) participants refused to undergo their allocated intervention (3 RYGB, 1 LAGB, 3 LWLI) and 1 RYGB was excluded for current smoking. Twenty subjects underwent RYGB, 21 LAGB, and 20 LWLI with retention at 12 months of 90%, 86%, and 70%, respectively. In the ITT cohort with multiple imputation for missing data, RYGB participants had the greatest weight loss compared to LAGB and LWLI with average weight loss of 27%, 17%, 10% from baseline, respectively (p<.0001). Partial/complete remission of diabetes was 50%/17% in RYGB, 27%/23% in LAGB and 0%/0% in LWLI (p=.0005/.047, partial/complete) and there were significant reductions in medication usage in both surgical groups. There were no deaths and 3 serious adverse events; 1 RYGB ulcer was treated medically and 2 LAGB were re-hospitalized for dehydration.
CONCLUSIONS
This study highlights several potential challenges to successfully completing a larger RCT for diabetes and obesity treatment in those with BMI 30–40 kg/m2, including the difficulties associated with recruiting and randomizing patients to surgical versus non-surgical interventions. Preliminary results show that RYGB was the most effective treatment followed by LAGB for both weight loss and diabetes outcomes at one year.