The Significance of Intact Vagal Innervation for the GLP-1 Induced Inhibition of Gastric Emptying, Appetite and Food Intake
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Gastric emptying
研究概览
简要总结
The aim of this study is to investigate the role of transmission via the vagal nerve for the effect of Glucagon-like peptide-1 (GLP-1) in respect to gastric emptying, appetite and food intake.
The hypothesis is that a great deal of the effects of GLP-1 is mediated via the nervous system and for this reason the researchers will investigate individuals with and without intact nervous supply.
详细描述
GLP-1 is a potent enterogastron and incretin hormone. It is rapidly inactivated by dipeptidyl peptidase IV so only 10-15% enters the systemic circulation. This has led to the hypothesis that GLP-1 interact locally with afferent sensory nerve fibers. We investigated the role of intact vagal innervations on the effect of GLP-1 on the food intake, gastric emptying (GE) and appetite.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •truncal vagotomy
- •normal hemoglobin
- •informed consent
- •Age, gender and weight matched controls
- •normal hemoglobin
- •informed consent
排除标准
- •type 1 diabetes mellitus or type 2 diabetes mellitus
- •body mass index > 30 kg/m2
- •inflammatory bowel disease
- •intestinal resection
- •nephropathy (serum creatinine > 150 µM and/or albuminuria)
- •liver disease (ALAT and/or ASAT > 2 x normal value)
- •treatment with medicine which cannot be paused for 12 hours
研究组 & 干预措施
Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
干预措施: Saline (Other)
Cardia
truncally vagotomized subjects (due to esophagus resection)
干预措施: Saline (Other)
Healthy controls
Healthy control subjects
干预措施: Saline (Other)
Vago
Truncally vagotomized subjects (due to duodenal ulcer operation)
干预措施: GLP-1 (Drug)
Cardia
truncally vagotomized subjects (due to esophagus resection)
干预措施: GLP-1 (Drug)
Healthy controls
Healthy control subjects
干预措施: GLP-1 (Drug)
结局指标
主要结局
Gastric emptying
时间窗: four hours
Gastric emptying will be assessed using a liquid meal with 1.5 g paracetamol added and continuous blood sampling for measuring paracetamol concentration during four hours
Appetite
时间窗: four hours
Hunger, satiation, and fullness will be assessed before, during and after a liquid meal with 1.5 g paracetamol added using a visual analog scale (VAS)
Food intake
时间窗: five hours
After the liquid meal test, the volunteers will be offered a meal to assessed their ad libitum food intake
次要结局
- plasma glucose(four hours)
- serum insulin and c-peptide(four hours)
- plasma glucagon(four hours)
- plasma GLP-1(four hours)
- endogenous GLP-1(four hours)
- plasma GIP(four hours)
- serum paracetamol(four hours)
研究者
Jonatan I Bagger
MD
University Hospital, Gentofte, Copenhagen