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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

ConditionsBariatric SurgeryHormonal ResponsePost Bariatric Hypoglycemia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorChulalongkorn University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Sleeve gastrectomy with duodenojejunal bypass

    Procedure/Surgery

    Novel bariatric procedure

  • Roux-en-Y gastric bypass

    Procedure/Surgery

    Standard bariatric procedure

Treatment groups

32 Participants
are divided into 2 treatment groups
Group A: Sleeve gastrectomy with duodenojejunal bypassExperimental treatment 1 intervention
Group B: Roux-en-Y gastric bypassActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hormonal response

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

Secondary outcomes

1

Post-bariatric hypoglycemia

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.

Time frame
Post-operative 6-24 months

Other outcomes

Sponsors and contacts

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Chulalongkorn University

Lead sponsor

Ratchadapiseksompotch Research Fund

Collaborator

Source ClinicalTrials.gov
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