Bariatric Surgery, Hormonal Response, Post Bariatric Hypoglycemia
Conditions
Keywords
Bariatric Surgery, Hormonal Response, Post bariatric hypoglycemia
Brief 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.
Detailed 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.
Interventions
PROCEDURESleeve gastrectomy with duodenojejunal bypass
Novel bariatric procedure
PROCEDURERoux-en-Y gastric bypass
Standard bariatric procedure
Sponsors
Chulalongkorn University
Ratchadapiseksompotch Research Fund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hormonal response | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-bariatric hypoglycemia | 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. |
Countries
Thailand
Contacts
CONTACTPrimploy Greeviroj, M.D., M.Sc.
PRINCIPAL_INVESTIGATORPatchaya Boonchaya-anant, M.D.
King Chulalongkorn Memorial Hospital
Outcome results
None listed