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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

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
18-60 years
All
Phase N/A

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Overview

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.

Description

Novel bariatric surgical techniques have been developed under the concept of "Sleeve-Plus" procedures, which combine sleeve gastrectomy with intestinal bypass to achieve the metabolic benefits of bypass surgery, including reduced nutrient absorption, while potentially minimizing postoperative complications. Several variations of the Sleeve-Plus procedure have been developed, with laparoscopic sleeve gastrectomy with duodenojejunal bypass (LSG-DJB) being one of the most widely adopted techniques developed in Asia. Previous studies have demonstrated that LSG-DJB is comparable to laparoscopic Roux-en-Y gastric bypass (LRYGB) in terms of weight loss, glycemic control, and resolution of obesity-related comorbidities. However, to date, no studies have evaluated changes in gastrointestinal hormone responses following LSG-DJB. This study aims to provide evidence regarding the hormonal changes associated with LSG-DJB compared with the standard laparoscopic Roux-en-Y gastric bypass (LRYGB) procedure. Investigators hypothesize that LSG-DJB may be associated with a lower incidence of post-bariatric hypoglycemia compared with LRYGB, while offering a less technically complex surgical procedure and potentially reducing the risk of other postoperative complications.

Eligibility

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

Study details
    Bariatric Surgery
    Hormonal Response
    Post Bariatric Hypoglycemia

NCT07747779

Chulalongkorn University

8 August 2026

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