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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Sleeve gastrectomy with duodenojejunal bypass
  Novel bariatric procedure
• Процедура Roux-en-Y gastric bypass
  Standard bariatric procedure

Первичные конечные точки

• Hormonal response [Срок оценки: Post-operative 6-24 months]

Вторичные конечные точки (1)

• Post-bariatric hypoglycemia [Срок оценки: Post-operative 6-24 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• King Chulalongkorn Memorial Hospital — Pathum Wan

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07747779 · 0240/67 · RA68/004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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