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The Endocrine Colon in Humans (Colon)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04159181
Recruitment Status : Active, not recruiting
First Posted : November 12, 2019
Last Update Posted : November 12, 2019
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Simon Veedfald, University of Copenhagen

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) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Investigations of the Endocrine Colon in Healthy Individuals
Actual Study Start Date : July 16, 2018
Actual Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

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.




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04159181


Locations
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Denmark
University of Copenhagen
Copenhagen, Capital, Denmark, 2200
Hvidovre University Hospital
Hvidovre, Capital, Denmark, 2650
Sponsors and Collaborators
University of Copenhagen
Hvidovre University Hospital
Investigators
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Study Director: Jens J Holst, MD, Dr.med. University of Copenhagen
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Responsible Party: Simon Veedfald, Investigator, University of Copenhagen
ClinicalTrials.gov Identifier: NCT04159181    
Other Study ID Numbers: CBC-COLON-18
First Posted: November 12, 2019    Key Record Dates
Last Update Posted: November 12, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Simon Veedfald, University of Copenhagen:
Colon
PYYs
GLP-1
Gut peptides
Fermentation
Lactulose
human
Additional relevant MeSH terms:
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Lactulose
Picosulfate sodium
Gastrointestinal Agents
Cathartics