Gastric Bypass vs Sleeve Gastrectomy for Type 2 Diabetes Mellitus: A Randomized Controlled Trial.
Lee WJ, Chong K, Ser KH, Lee YC, Chen SC, Chen JC, Tsai MH, Chuang LM.
Diabetic Center, Min-Sheng General Hospital, National Taiwan University, 168 Jingguo Rd, Taoyuan City, Taoyuan County 330, Taiwan, Republic of China. [Ссылки доступны только зарегистрированным пользователям ].
Abstract
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 ([Ссылки доступны только зарегистрированным пользователям ]).
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