Gastric bypass vs sleeve gastrectomy for type 2 diabetes mellitus: a randomized controlled trial.

Lee, Wei-Jei; Chong, Keong; Ser, Kong-Han; Lee, Yi-Chih; Chen, Shu-Chun; Chen, Jung-Chien; Tsai, Ming-Han; Chuang, Lee-Ming

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 We studied 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. Trial Registration clinicaltrials.gov Identifier: NCT00540462 (http://www.clinicaltrials.gov).