Hormonal and Metabolic Aspects of Endoscopic Sleeve Gastroplasty
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in ghrelin (pg/ml)
研究概览
简要总结
The investigators of the study want to investigate the complex interactions between glucose metabolism, food intake/weight loss, and different appetite regulating hormones after ESG in comparison with conventional laparoscopic sleeve gastrectomy (LSG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Scheduled for endoscopic or laparoscopic sleeve at Hvidovre Hospital
- •HbA1c < 48 mmol/mol before surgery, and no history of diabetes
- •HbA1c < 48 mmol/mol and fasting plasma glucose < 6.1 mmol/l at inclusion
排除标准
- •Hemoglobin < 6.5 mmol/l at inclusion
- •Pregnancy or breast feeding
- •Medication affecting the planned examinations
研究组 & 干预措施
Endoscopic sleeve gastroplasity operated patients
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
干预措施: Endoscopic sleeve gastroplasty (Procedure)
Laparoscopic sleeve gastrectomy operated patients
Four test days, two days before surgery, one test day three months after surgery and one test day one year after surgery
干预措施: Laparoscopic sleeve gastrectomy (Procedure)
结局指标
主要结局
Changes in ghrelin (pg/ml)
时间窗: 240 minutes
Changes in ghrelin after a solid meal test compared before and after surgery
次要结局
- Changes in gut hormone response before and after sugery (pmol/L)(240 minutes)
研究者
Nora Elisabeth Hedbäck
Principal Investigator
Hvidovre University Hospital