Investigations of the Endocrine Colon in Healthy Individuals
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- GLP-1
研究概览
简要总结
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
详细描述
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
We aim to determine the contribution of the colon to the fasting and postprandial release of gut peptides such as glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Young healthy men will be examined on three occasions at a clinical research Facility after an overnight fast. On one occasion the colon will also be emptied using a cathartic (picoprep). On two occasions an oral solution of lactulose will be administered to stimulate fermentation by colonic bacteria.
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
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy young men (self-reported)
- •BMI between 18,5-24,9 kg/m^2
排除标准
- •Diabetes mellitus (elevated fasting plasma glucose or HbA1c)
- •Family history of diabetes mellitus
- •Intestinal disease (e.g. inflammatory bowel disease, malabsorption)
- •Family history of intestinal diseases
- •Previous gastrointestinal surgery
- •BMI >25 kg/m^2
- •Tobacco use
- •Alcohol consumption > 14 standard drinks/week
- •Kidney, Heart- or Liver disease
- •Treatment with prescription drugs that can not be held for 12h
- •Constipation
- •Accelerated or delayed gastric emptying
- •Absence of daily bowel movements
- •Vegetarian lifestyle
- •> than 3kgs weightloss or weight gain within 3 months
- •Haemoglobin concentration < 8,0mmol/L
- •Bleeding diathesis
- •Latex or bandaid allergies
研究组 & 干预措施
Day B
After an overnight fast participants will drink 200mL of water
干预措施: Placebo (water) (Other)
Day C
After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water).
干预措施: Picoprep (Other)
Day C
After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water).
干预措施: Lactulose (Other)
Day A
After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).
干预措施: Lactulose (Other)
结局指标
主要结局
GLP-1
时间窗: -60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min
Plasma concentrations of glucagon-like peptide-1 (GLP-1)
次要结局
- PYY(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
- Ghrelin(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
- Glucagon(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
- Motilin(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
- Hydrogen breath test(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
- Neurotensin(-60, -45, -30, -15, 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240, 255, 270. 285, 300 min)
研究者
Simon Veedfald
Investigator
University of Copenhagen