A Comparative Study of the Effects of Roux en Y Gastric Bypass and Sleeve Gastrectomy on Postprandial Gut Hormone Responses, Glycemia and Lipid Profile, Weight Loss, and Indices of Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in postprandial ghrelin responses
研究概览
简要总结
Morbidly obese patients undergoing either Roux en Y gastric bypass or sleeve gastrectomy were examined preoperatively, 3, 6, and 12 months after surgery. On each occasion, anthropometric data were collected, resting metabolic rate was measured, and the patients underwent a panel of cardiovascular examinations (heart rate variability, baroreflex sensitivity, heart ultrasound). Following that, they consumed a test meal and completed visual analog scales for the subjective assessment of hunger and fullness every 30 minutes for 3 hours. At the same time points, blood samples were collected for the consequent measurement of glucose, insulin, lipids, and gastrointestinal hormones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI >40 kg/m2
- •Age between 18 and 65 years
- •Proven failure to lose weight through non-surgical interventions
排除标准
- •Serious and life threatening comorbidities (renal, cardiac, liver failure, or malignancy)
- •Patients' inability to adhere to postsurgical instructions
- •Alcohol or other substance abuse
- •Concurrent psychiatric illness
研究组 & 干预措施
Gastric bypass bariatric surgery
Patients in this arm underwent Roux-en-Y gastric bypass bariatric surgery for the treatment of morbid obesity
干预措施: Bariatric surgery (Procedure)
Sleeve gastrectomy bariatric surgery
Patients in this arm underwent sleeve gastrectomy bariatric surgery for the treatment of morbid obesity
干预措施: Bariatric surgery (Procedure)
结局指标
主要结局
Change in postprandial ghrelin responses
时间窗: 3, 6, and 12 months
Change in the cumulative postprandial response for ghrelin
Change in postprandial GLP-1 responses
时间窗: 3, 6, and 12 months
Change in the cumulative postprandial response for GLP-1
Change in postprandial PYY responses
时间窗: 3, 6, and 12 months
Change in the cumulative postprandial response for PYY
次要结局
- Change in weight(3, 6, and 12 months)
- Change in postprandial glycemia(3, 6, and 12 months)
- Change in postprandial insulinemia(3, 6, and 12 months)
- Change in postprandial triglyceridemia(3, 6, and 12 months)
研究者
Alexandros Kokkinos
Associate Professor in Internal Medicine
National and Kapodistrian University of Athens