Clinical trial

Comparison of Hormonal Response to a Mixed-Meal Tolerance Test After Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy With Duodenojejunal Bypass in Patients With Super Morbid Obesity

Recruiting now · Not applicable · 1 countries · Registry ID NCT07747779

Recruiting nowNot applicableInterventional

What this study is about

Obesity is a major global health problem. Bariatric surgery is the most effective treatment, leading to substantial weight loss and improvement in obesity-related comorbidities. The most commonly performed procedures are Laparoscopic Roux-en-Y gastric bypass (LRYGB) and Laparoscopic sleeve gastrectomy (LSG). LRYGB is typically selected for patients with a BMI exceeding 50 kg/m2. Recently, LSG with duodenojejunal bypass (LSG-DJB) has been introduced. To date, no randomized controlled trial has compared LRYGB and LSG-DJB in patients with super morbid obesity, particularly regarding postoperative hormonal responses. This study aims to address this gap. If LSG-DJB results in a lower incidence of post-bariatric hypoglycemia than LRYGB, it would support its clinical benefit. Evaluation of GLP-1, GIP, glucagon, and insulin responses will clarify mechanisms underlying weight loss and postprandial glycemic changes.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionBariatric Surgery, Hormonal Response, Post Bariatric Hypoglycemia

Full registry criteria

Inclusion Criteria: * Patients with an indication for bariatric surgery * BMI 50-60 kg/m2 * Patients who are motivated to lose weight but have not achieved successful weight reduction despite optimal medical therapy and exercise under physician supervision Exclusion Criteria: * Patients with diabetes mellitus * Patients with severe comorbid conditions that contraindicate surgery, such as advanced heart disease or chronic kidney failure * Patients with a history of previous bariatric surgery * Patients with gastroesophageal reflux disease refractory to medical therapy, large hiatal hernia, or endoscopic findings of reflux esophagitis grade C or D, or Barrett esophagus * Patients with psychiatric disorders that impair eating behavior control * Patients with a history of pancreatitis, pancreatic disease, or inflammatory bowel disease * Patients who have used steroids or GLP-1 receptor agonists within the past 2 months

Treatments and study arms

Sleeve gastrectomy with duodenojejunal bypass

Procedure

Novel bariatric procedure

Roux-en-Y gastric bypass

Procedure

Standard bariatric procedure

Primary outcomes

Hormonal responsePost-operative 6-24 months

To compare the hormonal responses following laparoscopic Roux-en-Y gastric bypass (LRYGB) versus laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB) using a mixed-meal tolerance test (MMTT) in patients with super morbid obesity

Study locations

1 locations were listed when this page was built. The first 40 are shown.

King Chulalongkorn Memorial Hospital🇹🇭 Pathum Wan, Bangkok, Thailand

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Primploy Greeviroj, M.D., M.Sc.Contact

Email · Call 66917142555

Patchaya Boonchaya-anant, M.D.Contact

Email · Call 66814416460

Patchaya Boonchaya-anant, M.D.Principal Investigator