The Endocrine Colon in Humans
- Conditions
- Healthy
- Interventions
- Other: LactuloseOther: Placebo (water)Other: Picoprep
- Registration Number
- NCT04159181
- Lead Sponsor
- University of Copenhagen
- Brief Summary
This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 10
- Healthy young men (self-reported)
- BMI between 18,5-24,9 kg/m^2
- 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
- Drug use
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Day C Lactulose After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water). Day B Placebo (water) After an overnight fast participants will drink 200mL of water Day C Picoprep After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water). Day A Lactulose After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).
- Primary Outcome Measures
Name Time Method GLP-1 -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)
- Secondary Outcome Measures
Name Time Method 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 Plasma concentrations of peptide YY (PYY)
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 Plasma concentrations of ghrelin
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 Plasma concentrations of glucagon
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 Plasma concentrations of motilin
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 Concentrations of hydrogen in exhaled air
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 Plasma concentrations of Neurotensin
Trial Locations
- Locations (2)
Hvidovre University Hospital
🇩🇰Hvidovre, Capital, Denmark
University of Copenhagen
🇩🇰Copenhagen, Capital, Denmark