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Effect of Banded Roux-en-Y Gastric Bypass versus Sleeve Gastrectomy on Diabetes Remission at 5 Years Among Patients with Obesity and Type 2 Diabetes: A Blinded Randomized Clinical Trial

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posted on 12.05.2022, 18:56 by Rinki Murphy, Lindsay D Plank, Michael G. Clarke, Nicholas J Evennett, James Tan, David DW Kim, Richard Cutfield, Michael WC Booth
Objective: To determine whether silastic-ring laparoscopic Roux-en-Y gastric bypass (SR-LRYGB) or laparoscopic sleeve gastrectomy (LSG) produces superior diabetes remission at 5 years.

Research Design and Methods: In a single-centre double-blind trial, 114 adults with type 2 diabetes and BMI 35-65kg/m2 were randomized to SR-LRYGB or LSG (1:1; stratified by age group, BMI group, ethnicity, diabetes duration and insulin therapy) using a web-based service. Diabetes and other metabolic medications were adjusted according to a prespecified protocol. The primary outcome was diabetes remission assessed at 5 years, defined by HbA1c <6% (42mmol/mol) without glucose-lowering medications. Secondary outcomes included changes in weight, cardiometabolic risk factors, quality of life, and adverse events.

Results: Diabetes remission after SR-LRYGB vs LSG occurred in 25/53 (47%) vs 18/55 (33%), adjusted odds ratio 4.5; 95% CI 1.6, 15.5; P=0.009; and 4.2; 95% CI 1.3, 13.4; P=0.015 in the intention-to-treat analysis. Percentage body weight loss was greater after SR-LRYGB than after LSG (absolute difference, 10.7%; 95% CI 7.3, 14.0; P<0.001). Improvements in cardiometabolic risk factors were similar, but high-density lipoprotein cholesterol increased more after SR-LRYGB. Early and late complications were similar in both groups. General health and physical functioning improved after both types of surgery, with greater improvement in physical functioning after SR-LRYGB. People of Māori or Pacific ethnicity (26%) had lower incidence of diabetes remission than those of European or other ethnicities (2/25 vs 41/83, P<0.001).

Conclusions: SR-LRYGB provided superior diabetes remission and weight loss compared to LSG at 5 years, with similarly low risk of complications.

Funding

This investigator-initiated study was funded primarily through Waitemata District Health Board which provides limited public-funded bariatric surgery (approximately 100 cases annually). Additional funding for blood sample storage and a research nurse salary was provided by Johnson and Johnson (NZ), Covidien (NZ), Auckland Medical Research Foundation and Obex (NZ). Maurice Wilkins Centre for Biodiscovery provided funding for assistance with body composition analysis at 5 years.

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