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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Hormonal response
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Sleeve gastrectomy with duodenojejunal bypass
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.
干预措施: Sleeve gastrectomy with duodenojejunal bypass (Procedure)
Roux-en-Y gastric 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.
干预措施: Roux-en-Y gastric bypass (Procedure)
结局指标
主要结局
Hormonal response
时间窗: 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
次要结局
- Post-bariatric hypoglycemia(Post-operative 6-24 months)