The Endocrine Colon in Humans

• Sponsor: University of Copenhagen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04159181
• Collaborator: Hvidovre University Hospital (Other)
• Enrollment: 10
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 23.5
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Lactulose; Other: Picoprep; Other: Placebo (water)	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• 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.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)
• Primary Purpose: Basic Science
• Official Title: Investigations of the Endocrine Colon in Healthy Individuals
• Actual Study Start Date: Jul 16, 2018
• Actual Primary Completion Date: Jul 31, 2019
• Anticipated Study Completion Date: Jul 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

   Plasma concentrations of glucagon-like peptide-1 (GLP-1)

Secondary Outcome Measures

1. 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)

2. 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

3. 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

4. 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

5. 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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Copenhagen	Copenhagen	Capital	Denmark	2200
2	Hvidovre University Hospital	Hvidovre	Capital	Denmark	2650

Sponsors and Collaborators

• University of Copenhagen
• Hvidovre University Hospital

Investigators

• Study Director: Jens J Holst, MD, Dr.med., University of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Simon Veedfald, Investigator, University of Copenhagen
• ClinicalTrials.gov Identifier: NCT04159181
• Other Study ID Numbers: CBC-COLON-18
• First Posted: Nov 12, 2019
• Last Update Posted: Nov 12, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Simon Veedfald, Investigator, University of Copenhagen: Colon; PYYs; GLP-1; Gut peptides; Fermentation; Lactulose; human
• Additional relevant MeSH terms: Lactulose; Picosulfate sodium

Study Results

No Results Posted as of Nov 12, 2019