Comparing One-anastomosis and Roux-en-Y Gastric Bypass Surgeries for Type 2 Diabetes in East Asian Adults

What this Trial Is About

Researchers are evaluating two types of metabolic surgery for people with obesity complicated by type 2 diabetes mellitus T2DM. The study compares one-anastomosis gastric bypass OAGB and Roux-en-Y gastric bypass RYGB, both known surgical treatments for weight loss and metabolic improvement. This multi-center, randomized, open-label trial aims to generate high-level evidence on the effectiveness and safety of these surgeries in Asian patients, focusing mainly on diabetes remission rates. Participants will be randomly assigned to receive either laparoscopic OAGB or laparoscopic RYGB, each performed according to a standard procedure. OAGB involves a specific gastrointestinal anastomosis with defined limb lengths, while RYGB uses a different stomach pouch size and limb configuration. The surgeries will be followed up over five years, with a target to keep follow-up loss under 20% and maintain data completeness above 95%. During the study, participants will undergo regular assessments including blood glucose monitoring, HbA1c measurements, weight loss tracking, and evaluation of diabetes medication usage. Other outcomes include surgery time, hospital stay length, quality of life questionnaires, and monitoring for surgical complications and symptoms like gastroesophageal reflux and dumping syndrome. The primary outcome is the complete remission rate of T2DM one year after surgery, with additional long-term measures collected over five years.

Efficacy and Safety of One-anastomosis Versus Roux-en-Y Gastric Bypass for Type 2 Diabetes Remission