The Endocrine Colon in Humans

Healthy Clinical Trial

— Colon  

Official title:

Investigations of the Endocrine Colon in Healthy Individuals

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04159181
• Other study ID #: CBC-COLON-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: November 2019
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 1, 2020
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Lactulose
Oral solution lactulose (20g lactulose/200mL water).
• Picoprep
Cathartic to accomplish an evacuation of the colonic content.
• Placebo (water)
oral administration of Water (200mL).

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Capital
Denmark	Hvidovre University Hospital	Hvidovre	Capital

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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