Comparison of Sleeve Gastrectomy With and Without Duodenojejunal Bypass for Treating Type 2 Diabetes in Adults

What this Trial Is About

Researchers are investigating the effects of two types of metabolic surgeriessleeve gastrectomy SG with duodenojejunal bypass DJB and SG aloneon patients with type 2 diabetes mellitus T2DM who have poor blood sugar control despite current medical treatments but still retain some pancreatic beta-cell function. The study targets patients using insulin for less than 10 years or those taking diabetic medications with HbA1c levels of 7.0% or higher for less than 10 years. The goal is to compare which surgical approach provides better diabetes control in this group. In this randomized trial, one group will receive sleeve gastrectomy alone, where part of the stomach is surgically reduced using a bougie tube for guidance. The other group will undergo sleeve gastrectomy combined with duodenojejunal bypass, which involves rerouting the small intestine to bypass part of the duodenum and jejunum, potentially affecting nutrient absorption. Both surgical procedures are performed with specific technical details, such as the size and location of stapling and anastomosis. The study will follow participants for up to 10 years, assessing various health outcomes over time. Participants will be monitored for diabetes remission rates, hypertension and hyperlipidemia improvements, nutritional deficiencies, changes in body weight and composition, quality of life, and complications both early within 30 days and late beyond 30 days after surgery. Assessments will take place at multiple intervals, including 1, 3, 5, and 10 years after surgery. The study aims to provide long-term data on the metabolic effects and safety of these surgical options for T2DM treatment in Asian patients with moderate obesity.

Comparisons of Metabolic Effect of Sleeve Gastrectomy With Duodenojejunal Bypass and Sleeve Gastrectomy (MEDUSA): A Multicenter Randomized Controlled Trial