King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330, Thailand
Location status: Recruiting
NCT Number: NCT07747779
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Pathum Wan, Bangkok, 10330, Thailand
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Novel bariatric procedure
Standard bariatric procedure
Time frame: Post-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
Time frame: Post-operative 6-24 months
To compare the occurrence of postprandial hypoglycemia 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.
Interested in participating?
Request InfoChulalongkorn University
Other
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
Acronym: CU BYPASS-DJB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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