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