Influence of Gut Hormones on Food Intake After Roux-en-Y Gastric Bypass Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Ad libitum food intake (changes in food intake)
研究概览
简要总结
The aim of this study is to examine the effect of GLP-1 and other gut-secreted hormones (glucagon, GIP, grelin and PYY) on food-intake, appetite and glucose metabolism after Roux-en-Y gastric bypass surgery.
详细描述
To do this the effect of combined GLP-1 receptor blockade by Exendin 9-39 and DPP-4-inhibition will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
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
- •Uncomplicated RYGB performed 3-12 month proir to the study. Fasting plasma glucose <7.0 mM and HbA1c < 48 mmol/mol 3 month after RYGB.
排除标准
- •Fasting plasma glucose >7.0 mM and HbA1c > 48 mmol/mol 3 month after RYGB. Hemoglobin <6.5mM. Previous anaphylaxis when treated with Januvia or Byetta. Allergy for sitagliptin. Dysregulated hypothyroidism. Use of antithyroid treatment. Late diabetic complications as retinopathy, renal insuffiency, neuropathy or previous pancreatitis. Bad compliance.
- •Complications to RYGB: Documented reactive hypoglycaemia, severe dumping (with vomiting, diarrhea or severe abdominal pain after food intake).
研究组 & 干预措施
Saline
Mixed meal test and ad libitum meal test duing infusion of saline
干预措施: Placebo (Other)
Exendin 9-39
Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min
干预措施: exendin 9-39 (Drug)
DPP-4 Inhibition
Mixed meal test and ad libitum meal test during intake of sitagliptin 100 mg * 2
干预措施: sitagliptin (Drug)
Exendin 9-39 / DPP 4-Inhibition
Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg * 2
干预措施: exendin 9-39 (Drug)
Exendin 9-39 / DPP 4-Inhibition
Mixed meal test and ad libitum meal test duing infusion of exendin 9-39, 900 pmol/kg/min and intake of sitagliptin 100 mg * 2
干预措施: sitagliptin (Drug)
结局指标
主要结局
Ad libitum food intake (changes in food intake)
时间窗: 3-12 month after RYGB
Evaluated by changes in food intake between the placebo day and the day with both administration of exendin 9-39 and DPP 4 Inhibitor
次要结局
- Glucose metabolism (iAUC of glucose and c-pep after a meal)(3-12 month after RYGB)
- Gut-derived hormone profiles (iAUC of GLP-1, PYY, GIP and glucagon after a meal)(3-12 month after RYGB)
- Appetite measurement (VAS-scores)(3-12 month after RYGB)
研究者
Maria Saur Svane
MD
Hvidovre University Hospital