The Endocrine Colon in Humans (Colon)

November 7, 2019 updated by: Simon Veedfald, University of Copenhagen

Investigations of the Endocrine Colon in Healthy Individuals

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital
      • Copenhagen, Capital, Denmark, 2200
        • University of Copenhagen
      • Hvidovre, Capital, Denmark, 2650
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 36 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GLP-1
Time Frame: -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)
-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
Time Frame: -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)
-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
Time Frame: -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
-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
Time Frame: -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
-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
Time Frame: -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
-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
Time Frame: -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
-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
Time Frame: -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
-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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Hvidovre University Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2018

Primary Completion (Actual)

July 31, 2019

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 9, 2018

First Submitted That Met QC Criteria

November 7, 2019

First Posted (Actual)

November 12, 2019

Study Record Updates

Last Update Posted (Actual)

November 12, 2019

Last Update Submitted That Met QC Criteria

November 7, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBC-COLON-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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