Table 2.

Recently Published Randomized Control Trials Comparing Bariatric Surgery to Non-Surgical Treatment of Obesity and Type 2 Diabetes

Study/Lead Author	Study Design	Populations and Procedures	Follow-up Duration	Outcomes	Limitations
Stampede I Trial/Schauer4	12-month, 3-arm, unblinded RCT at a single center	150 subjects, BMI 27–43, diagnosis of T2DM (A1c > 7.0%); Tx arms: medical therapy alone vs. medical therapy plus RYGB or sleeve gastrectomy	12 months	93% retention. Primary endpoint A1c ≤6.0% achieved by 12% medical group, 42% RYGB and 37% sleeve; EWL 13%, 88%, and 81% respectively; RYGB achieved endpoint with no medications; medical group increased medications; Adverse events requiring hospitalizations occurred in 9% medical, 22% RYGB and 8% sleeve.	Single center
Mingrone5	24-month, 3-arm, unblinded RCT at a single center	60 subjects, BMI > 35, T2DM duration ≥5 years, A1c ≥ 7.0%; Tx arms: conventional medical therapy, RYBG, open BPD	24 months	93% retention. Primary endpoint FPG <100 mg/dL and A1c <6.5% without medication. Achieved by 75% RYGB and 95% BPD; mean A1c 7.69%, 6.35%, 4.95% in medical, RYGB, and BPD groups, respectively; all surgical patients discontinued medications within 15 days surgery; 4 adverse events	Single center; diabetes remission in medical group not a goal, medical group less well characterized
The Diabetes Surgery Study/Ikramuddin6	12-month, 2-arm unblinded RCT at 4 teaching hospitals in US and Taiwan	120 subjects, A1c ≥8.0%, BMI 30.0–39.9, C peptide >1.0 ng/mL, T2DM duration ≥ 6 mos.; Tx arms: lifestyle-intensive medical management intervention and medical management plus RYGB	12 months	95% retention. Primary endpoint A1c <7.0%, LDL < 100 mg/dL, SBP< 130 mm/Hg. Achieved by 49% RYGB and 19% medical subjects; RYGB subjects required 3.0 less medications and lost 26.1% initial body weight vs. 7.9% in the medical group; 22 serious adverse events in RYGB	High complication rate; composite outcome driven primarily by T2DM remission
Dixon26	24- month, 2-arm, unblinded RCT at a single site	60 subjects, BMI > 30 and < 40, T2DM diagnosed < 2 years, Tx arms: Conventional T2DM therapy vs. LAGB with conventional T2DM care	24 months	92% retention; Primary endpoints FPG < 126 mg/dL and A1c < 6.2% without medication; secondary measures weight and components of metabolic syndrome; T2DM remission achieved by 73% surgical and 13% conventional-therapy. 20.7% vs. 1.7% weight loss in surgical vs. conventional groups; no serious complications	Recent T2DM diagnosis
O’Brien27	24-month, 2-arm, unblinded RCT at a single site	80 subjects BMI 30–35; Tx arms: pharmacotherapy/lifestyle (nonsurgical) and LAGB	24 months	98% LAGB retention, 83% nonsurgical retention; Primary end point weight loss. 21.6% initial weight lost and 87.2% excess weight lost in LAGB; 5.5% initial weight lost and 21.8% excess weight lost in nonsurgical. Metabolic syndrome (defined by the Adult Treatment Panel III criteria present initially in 15 (38%) subjects in each group, at 24 mos. present in 8 nonsurgical and 1 surgical subject	Less focus on T2DM