Gastric bypass versus sleeve gastrectomy in patients with type 2 diabetes (Oseberg): a single-centre, triple-blind, randomised controlled trial

Abstract

The comparative effectiveness of various bariatric procedures on remission of type 2 diabetes remains debated. We aimed to compare the two most commonly used procedures, hypothesising higher remission rates of diabetes after gastric bypass than after sleeve gastrectomy. Methods:The Oseberg study is an ongoing triple-blind, randomised, single-centre trial taking place at Vestfold Hospital Trust, Norway. Adult patients with type 2 diabetes and obesity were randomly assigned (1:1) to receive either gastric bypass or sleeve gastrectomy. Randomisation was performed with a computerised random number generator using block sizes of 10. Treatment allocation was concealed using sealed opaque envelopes, and was masked from participants, study personnel and outcome assessors. Primary outcomes were, first, the proportion of participants with complete remission of diabetes; glycated haemoglobin 6•0% (42 mmol/mol) or less with no diabetes medication, and, second, beta-cell function modelled from an intravenous glucose tolerance test at one year. Analyses were performed according to intention-to-treat and per-protocol principles. The trial is registered at ClinicalTrials.gov with identifier: NCT01778738.

Comparison of the effect of Roux‐en‐Y gastric bypass and sleeve gastrectomy on remission of type 2 diabetes: A systematic review and meta‐analysis of randomized controlled trials

“…We detected two studies that had been performed in the same study population, and of these, only the study referring to a clinical trial registry number was included . Finally, 12 articles of 10 different RCTs, where of four had data on remission at different lengths of follow‐up, were included in the systematic review.…”

“…Half of the patients (n = 352) underwent RYGB, while the remaining half (n = 353) underwent SG. Five trials included only patients with T2DM, and these five had complete remission of T2DM (HbA1c < 6.0% or HbA1c ≤ 6.0%) as the primary or secondary endpoint. The remaining trials had weight loss as the main outcome and remission of T2DM as a secondary or exploratory outcome.…”

“…All studies, except for one, had adequately described the method of randomization. Methods of allocation concealment were properly described in half of the included trials , and only two studies were blinded (participants and study personnel), whereof one was triple blinded (participants, study personnel, and data analyser). All included studies were regarded as having low risk of attrition bias.…”

“…One of the studies with high risk of bias was heavily weighted (38.8%), and removal of this study from the analysis resulted in an effect estimate of 1.33 (1.09‐1.64), P = .0056. In addition, after restricting the analysis to studies that only included patients with T2DM, the effect estimate (RR) increased: 1.39 (0.94‐2.07), P = .10.…”

“…Reviews including both RCTs and retrospective studies have concluded that RYGB is associated with better resolution and control of T2DM than SG, while one review found no difference between the procedures . However, some important trials were missing from these reviews, and two larger RCTs have recently been published …”