The Endocrine Colon in Humans

Not Applicable

• Conditions: Healthy

• 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.

Study Timeline

• Study First Submitted: 2018-07-09
• Study Start: 2018-07-16
• Primary Completion: 2019-07-31
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Study First Posted: 2019-11-12
• Last Update Posted: 2019-11-12
• Study Completion: 2020-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Healthy young men (self-reported)
• BMI between 18,5-24,9 kg/m^2

Exclusion Criteria

• 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

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)

University of Copenhagen; 🇩🇰 Copenhagen, Capital, Denmark

Hvidovre University Hospital; 🇩🇰 Hvidovre, Capital, Denmark