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

Abstract

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-center, double-blind trial, 114 adults with type 2 diabetes and BMI 35–65 kg/m2 were randomly assigned 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% (42 mmol/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 versus LSG occurred in 25 (47%) of 53 vs. 18 (33%) of 55 patients (adjusted odds ratios 4.5 [95% CI 1.6, 15.5; P = 0.009] and 4.2 [1.3, 13.4; P = 0.015] in the intention-to-treat analysis). Percent 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 HDL 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 New Zealand European or other ethnicities (2 of 25 vs. 41 of 83; P < 0.001). CONCLUSIONS SR-LRYGB provided superior diabetes remission and weight loss compared with LSG at 5 years, with similar low risks of complications.

Metabolic bariatric surgery as a therapeutic option for patients with type 2 diabetes: A meta‐analysis and network meta‐analysis of randomized controlled trials

“…The present meta‐analysis confirms that metabolic surgery has a greater efficacy than non‐surgical therapy in determining reduction of HbA1c and diabetes remission in overweight and obese patients with T2D. This result is in line with those of previous meta‐analyses 13,70 that also included shorter‐term studies (possibly distorting the estimates of longer‐term efficacy of different therapeutic approaches) and which could not include some recent randomized trials 25,58,64,71 …”

“…Out of 36 trials fulfilling all the inclusion criteria, 19 enrolled only patients with T2D, 24‐47 whereas 17 45,48‐62 included wider populations and provided separate subgroup analyses for patients affected by diabetes. Thirteen 25‐28,30,33‐38,61,63 and 26 trials 24,29,31,32,34,37,39,40,45,46,48‐59,62‐65 compared metabolic surgery with LSI/MT and with other types of metabolic surgery, respectively. Three trials compared metabolic surgery both with LSI/MT and other types of metabolic surgery 34,37,63 …”

“…Thirteen [25][26][27][28]30,[33][34][35][36][37][38]61,63 and 26 trials 24,29,31,32,34,37,39,40,45,46,[48][49][50][51][52][53][54][55][56][57][58][59][62][63][64][65] compared metabolic surgery with LSI/MT and with other types of metabolic surgery, respectively. Three trials compared metabolic surgery both with LSI/MT and other types of metabolic surgery.…”

Bariatric Surgery and Psychological Health: A Randomised Clinical Trial in Patients with Obesity and Type 2 Diabetes

“…In brief, the trial was a randomised, two-arm, double-blind, single-centre study in Auckland, New Zealand, involving 114 patients with obesity and type 2 diabetes. The primary outcome was diabetes remission at 5 years[ 37 ]. The current secondary analysis aimed to investigate the impact of SR-RYGB and SG on depressive symptoms, anxiety symptoms and quality of life, as well as the role of pre-surgical psychological health on bariatric surgery outcomes, analysed up to 5 years post-surgery.…”

Reversion and remission are promising targets for patients with type 2 diabetes mellitus

“…несмотря на большее снижении массы тела после первого способа оперативного вмешательства, частота достижения ремиссии сд2 значимо не различалась (33% и 26% соответственно; р=0,63) [23]. в другом двойном слепом исследо- [24]. как и любое оперативное вмешательство, бх ассоциируется с риском осложнений, хотя он сравнительно невелик.…”