The Endocrine Colon in Humans

Study Overview
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Brief Summary
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This study will examine the role of the colon as an endocrine organ with a focus on the secretion of gastrointestinal peptides.

Detailed Description
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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.

Official Title
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Investigations of the Endocrine Colon in Healthy Individuals

Conditions
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Healthy

Intervention / Treatment
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* Other: Lactulose
* Other: Picoprep
* Other: Placebo (water)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Day A<br>After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water). | Other: Lactulose<br>* Oral solution lactulose (20g lactulose/200mL water).<br>|
| Experimental: Day B<br>After an overnight fast participants will drink 200mL of water | Other: Placebo (water)<br>* oral administration of Water (200mL).<br>|
| Experimental: Day C<br>After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water). | Other: Lactulose<br>* Oral solution lactulose (20g lactulose/200mL water).<br>Other: Picoprep<br>* Cathartic to accomplish an evacuation of the colonic content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GLP-1 | Plasma concentrations of glucagon-like peptide-1 (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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PYY | Plasma concentrations of peptide YY (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 | 
| Hydrogen breath test | Concentrations of hydrogen in exhaled air | -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 | Plasma concentrations of 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 | 
| Motilin | Plasma concentrations of 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 | 
| Neurotensin | Plasma concentrations of 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 | 
| Glucagon | Plasma concentrations of 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon, PYYs, GLP-1, Gut peptides, Fermentation, Lactulose, human