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NCT Number: NCT07747779

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Chulalongkorn Memorial Hospital

Pathum Wan, Bangkok, 10330, Thailand

Location status: Recruiting

Location contact

Natnicha Houngngam, M.Sc.

SUB_INVESTIGATOR

Patchaya Boonchaya-anant, M.D.

CONTACT

[email protected]

66814416460

Patchaya Boonchaya-anant, M.D.

PRINCIPAL_INVESTIGATOR

Pattharasai Kachornvitaya, M.D.

SUB_INVESTIGATOR

Prangareeya Santisitthanon, B.Sc.

SUB_INVESTIGATOR

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

CONTACT

[email protected]

66917142555

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

SUB_INVESTIGATOR

Suthep Udomsawaengsup, M.D.

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleeve gastrectomy with duodenojejunal bypass

Procedure

Novel bariatric procedure

Roux-en-Y gastric bypass

Procedure

Standard bariatric procedure

Primary outcomes

  1. Hormonal response

    Time frame: 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 outcomes

  1. Post-bariatric hypoglycemia

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+66917142555

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Collaborators

  • Ratchadapiseksompotch Research Fund

Registry information

Official study 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

Acronym: CU BYPASS-DJB

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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