The Influence of Cholecystectomy on Secretion of Incretin Hormones
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Postprandial GLP-1 response
研究概览
简要总结
The effect of cholecystectomy on postprandial plasma GLP-1 responses (primary endpoint) and glucose metabolism will be evaluated in 30 patients planned to undergo elective laparoscopic cholecystectomy.
详细描述
This is an observational, parallel-group study in 30 patients with gallstone disease and 10 healthy control subjects. In patients undergoing cholecystectomy a 4h-meal test (liquid mixed meal) will be conducted at baseline (1-2 weeks before surgery) and again within 4 weeks after the cholecystectomy. Healthy subjects will be submitted to a single 4h-meal test.
Secondary endpoints include changes in plasma glucose, insulin, glucagon, GIP, PYY, gastrin, CCK, fibroblast growth factor 19 (FGF-19) and bile acids. Furthermore, secondary endpoints include changes in gastric emptying (evaluated by the paracetamol method).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •caucasians above 18 years of age, having an elective cholecystectomy performed because of gallstone disease.
- •normal fasting plasma glucose and HbA1c
- •normal hgb
- •Normal gallbladder ejection fraction
排除标准
- •liver disease
- •kidney disease
- •ongoing infection
- •abdominal pain not related to gall stones
- •BMI <18,5 kg/m2 eller BMI >30 kg/m2
- •prior abdominal surgery
结局指标
主要结局
Postprandial GLP-1 response
时间窗: 240 min
Gut derived hormone secretion after a 4 h meal test measured in pmol/liter
次要结局
- plasma glucose(240 min)
- gastric emptying(240 min)
- Resting metabolic rate(240 min)
- insulin(240 min)
- PYY(240 min)
- GIP(240 min)
- CCK(240 min)
- Glucagon(240 min)
- FGF-19(240 min)
- Gastrin(240 min)
- Bile acids(240 min)
研究者
Henriette Holst Nerild
MD, Ph.D. student
University Hospital, Gentofte, Copenhagen