Clinical trial NCT04159181: The Endocrine Colon in Humans
Official title: Investigations of the Endocrine Colon in Healthy Individuals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: Colon
PYYs
GLP-1
Gut peptides
Fermentation
Lactulose
human
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2019-11-12
Enrollment: 10
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: GLP-1
timeFrame: -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
Secondary outcomes:
measure: PYY
timeFrame: -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
measure: Hydrogen breath test
timeFrame: -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
measure: Ghrelin
timeFrame: -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
measure: Motilin
timeFrame: -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
measure: Neurotensin
timeFrame: -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
measure: Glucagon
timeFrame: -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
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Capital
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
state: Capital
Study officials:
affiliation: University of Copenhagen
name: Jens J Holst, MD, Dr.med.
role: STUDY_DIRECTOR
References:
citation: Christiansen CB, Veedfald S, Hartmann B, Gauguin AM, Moller S, Moritz T, Madsbad S, Holst JJ. Colonic Lactulose Fermentation Has No Impact on Glucagon-like Peptide-1 and Peptide-YY Secretion in Healthy Young Men. J Clin Endocrinol Metab. 2022 Jan 1;107(1):77-87. doi: 10.1210/clinem/dgab666.