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

NCT07747779 | Recruiting DMC

• 2 other identifiers: 0240/67RA68/004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Bariatric Surgery; Hormonal Response; Post Bariatric Hypoglycemia

Keywords

Bariatric Surgery; Hormonal Response; Post bariatric hypoglycemia

Outcome Measures

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

  Post-operative 6-24 months

Secondary Outcomes (1)

• Post-bariatric hypoglycemia

  Post-operative 6-24 months

Study Arms (2)

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.

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.

Procedure: Roux-en-Y gastric bypass

Interventions

Sleeve gastrectomy with duodenojejunal bypass PROCEDURE

Novel bariatric procedure

Sleeve gastrectomy with duodenojejunal bypass

Roux-en-Y gastric bypass PROCEDURE

Standard bariatric procedure

Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• Ratchadapiseksompotch Research Fund: collaborator

Study Sites (1)

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

RECRUITING

Related Publications (9)

• 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.

  PMID: 17895322 BACKGROUND

• Praveen 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.

  PMID: 21870050 BACKGROUND

• Seki 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.

  PMID: 27644433 BACKGROUND

• Kasama 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.

  PMID: 19626382 BACKGROUND

• Huang 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.

  PMID: 24300921 BACKGROUND

• Uno 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.

  PMID: 28451928 BACKGROUND

• Lee 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.

  PMID: 35914520 BACKGROUND

• English 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.

  PMID: 29370995 BACKGROUND

• Picot 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.

  PMID: 19726018 BACKGROUND

MeSH Terms

Interventions

Gastric Bypass

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Patchaya Boonchaya-anant, M.D.

  King Chulalongkorn Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Primploy Greeviroj, M.D., M.Sc.

CONTACT

+66917142555; primploy.gre@chulahospital.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2026
• First Posted: August 5, 2026
• Study Start: August 8, 2024
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 6, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)