An interventional study of Sleeve gastrectomy with duodenojejunal bypass and Roux-en-Y gastric bypass in Bariatric Surgery, Hormonal Response and Post Bariatric Hypoglycemia, sponsored by Chulalongkorn University. Recruiting at 1 site in Thailand. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-06.
Sponsored by Chulalongkorn University · Not applicable, Interventional, and Treatment
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.
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.
706 studies on the registry are indexed under Hypoglycemia; 94 are open to participants now.
This study's planned enrollment of 32 is above the median of 28 across 534 interventional studies indexed under Hypoglycemia.
Browse Hypoglycemia studies →Chulalongkorn University is the lead sponsor of 322 studies on the registry; 66 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Sleeve gastrectomy with duodenojejunal bypass is a surgical technique in which the greater curvature of the stomach is resected and separated from the lesser curvature and antrum, reducing the gastric volume to approximately 80-150 mL (about 20% of the original capacity) using a 32-36 Fr bougie. Subsequently, the biliopancreatic limb is created by transecting the small intestine approximately 50-100 cm distal to the duodenojejunal (DJ) junction. A Roux (alimentary) limb measuring 150-200 cm in length is then constructed, followed by the creation of a duodenojejunostomy.
Procedure: Sleeve gastrectomy with duodenojejunal bypass
Roux-en-Y gastric bypass is a surgical technique in which the stomach is reduced to a small pouch with a volume of approximately 15-50 mL. The jejunum is then transected 40-50 cm distal to the duodenojejunal (DJ) junction and anastomosed to the gastric pouch to create the Roux (alimentary) limb, which is typically 75-150 cm in length. Finally, a jejunojejunostomy is performed to reconnect the small intestine.
Procedure: Roux-en-Y gastric bypass
Novel bariatric procedure
Standard bariatric procedure
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
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
Plan to share: No
Started Aug 2024 (actual). Primary completion is estimated for Jul 2027, 35 months after the start.
Of 169 non-industry interventional studies with no phase under Hypoglycemia, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 33. This study's planned 35 months is above that.
Counting every sponsor, half of 175 studies reached it within 17 months; a quarter within 7 and three quarters within 33.
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