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The Endocrine Colon in Humans

Investigations of the Endocrine Colon in Healthy Individuals

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04159181
Acronym
Colon
Enrollment
10
Registered
2019-11-12
Start date
2018-07-16
Completion date
2020-07-01
Last updated
2019-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Colon, PYYs, GLP-1, Gut peptides, Fermentation, Lactulose, human

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.

Interventions

OTHERLactulose

Oral solution lactulose (20g lactulose/200mL water).

Cathartic to accomplish an evacuation of the colonic content.

oral administration of Water (200mL).

Sponsors

Hvidovre University Hospital
CollaboratorOTHER
University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Healthy men studied on three occasions. Study A and B will be conducted in random order. Day C wil always be conducted as the last study day.

Eligibility

Sex/Gender
MALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
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 minPlasma concentrations of glucagon-like peptide-1 (GLP-1)

Secondary

MeasureTime frameDescription
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 minPlasma concentrations of ghrelin
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 minPlasma concentrations of peptide YY (PYY)
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 minConcentrations 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 minPlasma concentrations of Neurotensin
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 minPlasma 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 minPlasma concentrations of motilin

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026