Gastric Bypass vs Sleeve Gastrectomy for Type 2 Diabetes Mellitus A Randomized Controlled Trial

Objectives: To determine the efficacies of 2 weight-reducing operations on diabetic control and the role of duodenum exclusion. Design: Double-blind randomized controlled trial. Setting: Department of Surgery of the Min-Sheng General Hospital, National Taiwan University. Patients: Westudied 60 moderately obese patients (body mass index > 25 and < 35) aged > 30 to < 60 years who had poorly controlled type 2 diabetes mellitus (T2DM) (hemoglobin A(1c) [HbA(1c)] > 7.5%) after conventional treatment (> 6 months) from September 1, 2007, through June 30, 2008. Patients and observers were masked during the follow-up, which ended in 2009, 1 year after final enrollment. Interventions: Gastric bypass with duodenum exclusion (n = 30) vs sleeve gastrectomy without duodenum exclusion (n = 30). Main Outcome Measures: The primary outcome was remission of T2DM (fasting glucose < 126 mg/dL and HbA(1c) < 6.5% without glycemic therapy). Secondary measures included weight and metabolic syndrome. Analysis was by intention to treat. Results: Of the 60 patients enrolled, all completed the 12-month follow-up. Remission of T2DM was achieved by 28 (93%) in the gastric bypass group and 14 (47%) in the sleeve gastrectomy group (P =. 02). Participants assigned to gastric bypass had lost more weight, achieved a lower waist circumference, and had lower glucose, HbA(1c), and blood lipid levels than the sleeve gastrectomy group. No serious complications occurred in either group. Conclusions: Participants randomized to gastric bypass were more likely to achieve remission of T2DM. Duodenum exclusion plays a role in T2DM treatment and should be assessed.