Bariatric SurgeryCU BYPASS-DJBNCT07747779
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 study testing Sleeve gastrectomy with duodenojejunal bypass and Roux-en-Y gastric bypass in people with Bariatric Surgery and Hormonal Response, run by Chulalongkorn University at 1 site in Thailand.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery, Hormonal Response, Post Bariatric Hypoglycemia
- What is being tested?
- Sleeve gastrectomy with duodenojejunal bypass and Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteThailand
- Study dates
- 8 Aug 2024to 31 Jul 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
King Chulalongkorn Memorial Hospital
Pathum Wan, Bangkok, 10330
Primploy Greeviroj, M.D., M.Sc., 66917142555, primploy.gre@chulahospital.org
Patchaya Boonchaya-anant, M.D., 66814416460, Patchaya.B@chula.ac.th
About this study
Official title: 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
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.
Read the 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.
- Being tested
- Sleeve gastrectomy with duodenojejunal bypass, Roux-en-Y gastric bypass
- Keywords
- Bariatric Surgery, Hormonal Response, Post bariatric hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomy with duodenojejunal bypassProcedure or surgery
Novel bariatric procedure
Roux-en-Y gastric bypassProcedure or surgery
Standard bariatric procedure
| Study group | Role | What they receive |
|---|---|---|
| Sleeve gastrectomy with duodenojejunal bypass | Experimental | 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. Receives: Procedure: Sleeve gastrectomy with duodenojejunal bypass |
| Roux-en-Y gastric bypass | Active comparator | 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. Receives: Procedure: Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Post-operative 6-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2026
- Study start8 Aug 2024
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- Ratchadapiseksompotch Research Fund
- Responsible party
- Sponsor
- Investigators
- Patchaya Boonchaya-anant, M.D., Principal investigator, King Chulalongkorn Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07747779
- Sponsor's protocol ID
- 0240/67
- Other IDs
- RA68/004
- Acronym
- CU BYPASS-DJB
- Status last verified
- Aug 2026
- First submitted
- 31 Jul 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Goldfine AB, Mun EC, Devine E, Bernier R, Baz-Hecht M, Jones DB, Schneider BE, Holst JJ, Patti ME. Patients with neuroglycopenia after gastric bypass surgery have exaggerated incretin and insulin secretory responses to a mixed meal. J Clin Endocrinol Metab. 2007 Dec;92(12):4678-85. doi: 10.1210/jc.2007-0918. Epub 2007 Sep 25.
PubMed 17895322Praveen Raj P, Kumaravel R, Chandramaliteeswaran C, Rajpandian S, Palanivelu C. Is laparoscopic duodenojejunal bypass with sleeve an effective alternative to Roux en Y gastric bypass in morbidly obese patients: preliminary results of a randomized trial. Obes Surg. 2012 Mar;22(3):422-6. doi: 10.1007/s11695-011-0507-x.
PubMed 21870050Seki Y, Kasama K, Haruta H, Watanabe A, Yokoyama R, Porciuncula JP, Umezawa A, Kurokawa Y. Five-Year-Results of Laparoscopic Sleeve Gastrectomy with Duodenojejunal Bypass for Weight Loss and Type 2 Diabetes Mellitus. Obes Surg. 2017 Mar;27(3):795-801. doi: 10.1007/s11695-016-2372-0.
PubMed 27644433Kasama K, Tagaya N, Kanehira E, Oshiro T, Seki Y, Kinouchi M, Umezawa A, Negishi Y, Kurokawa Y. Laparoscopic sleeve gastrectomy with duodenojejunal bypass: technique and preliminary results. Obes Surg. 2009 Oct;19(10):1341-5. doi: 10.1007/s11695-009-9873-z. Epub 2009 Jul 21.
PubMed 19626382Huang CK, Goel R, Tai CM, Yen YC, Gohil VD, Chen XY. Novel metabolic surgery for type II diabetes mellitus: loop duodenojejunal bypass with sleeve gastrectomy. Surg Laparosc Endosc Percutan Tech. 2013 Dec;23(6):481-5. doi: 10.1097/SLE.0b013e3182950111.
PubMed 24300921Uno K, Seki Y, Kasama K, Wakamatsu K, Umezawa A, Yanaga K, Kurokawa Y. A Comparison of the Bariatric Procedures that Are Performed in the Treatment of Super Morbid Obesity. Obes Surg. 2017 Oct;27(10):2537-2545. doi: 10.1007/s11695-017-2685-7.
PubMed 28451928Lee CJ, Clark JM, Egan JM, Carlson OD, Schweitzer M, Langan S, Brown T. Comparison of Hormonal Response to a Mixed-Meal Challenge in Hypoglycemia After Sleeve Gastrectomy vs Gastric Bypass. J Clin Endocrinol Metab. 2022 Sep 28;107(10):e4159-e4166. doi: 10.1210/clinem/dgac455.
PubMed 35914520English WJ, DeMaria EJ, Brethauer SA, Mattar SG, Rosenthal RJ, Morton JM. American Society for Metabolic and Bariatric Surgery estimation of metabolic and bariatric procedures performed in the United States in 2016. Surg Obes Relat Dis. 2018 Mar;14(3):259-263. doi: 10.1016/j.soard.2017.12.013. Epub 2017 Dec 16.
PubMed 29370995Picot J, Jones J, Colquitt JL, Gospodarevskaya E, Loveman E, Baxter L, Clegg AJ. The clinical effectiveness and cost-effectiveness of bariatric (weight loss) surgery for obesity: a systematic review and economic evaluation. Health Technol Assess. 2009 Sep;13(41):1-190, 215-357, iii-iv. doi: 10.3310/hta13410.
PubMed 19726018