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Recruiting NCT07747779

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: A Prospective Single-Center Non-Inferiority Randomized Clinical Trial

Conditions: Bariatric Surgery, Hormonal Response, Post Bariatric Hypoglycemia

Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: No
Phase: NA
Enrollment: 32
Sponsor: Chulalongkorn University

Location: King Chulalongkorn Memorial Hospital Pathum Wan Bangkok

Summary

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.

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07747779). StuddyBuddy aggregates publicly available trial information.