Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2018-07-16
2020-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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Day A
After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).
Lactulose
Oral solution lactulose (20g lactulose/200mL water).
Day B
After an overnight fast participants will drink 200mL of water
Placebo (water)
oral administration of Water (200mL).
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).
Lactulose
Oral solution lactulose (20g lactulose/200mL water).
Picoprep
Cathartic to accomplish an evacuation of the colonic content.
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* BMI between 18,5-24,9 kg/m\^2
Exclusion Criteria
* 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
20 Years
40 Years
MALE
Yes
Sponsors
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Hvidovre University Hospital
OTHER
University of Copenhagen
OTHER
Responsible Party
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Simon Veedfald
Investigator
Principal Investigators
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Jens J Holst, MD, Dr.med.
Role: STUDY_DIRECTOR
University of Copenhagen
Locations
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University of Copenhagen
Copenhagen, Capital, Denmark
Hvidovre University Hospital
Hvidovre, Capital, Denmark
Countries
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References
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Christiansen CB, Veedfald S, Hartmann B, Gauguin AM, Moller S, Moritz T, Madsbad S, Holst JJ. Colonic Lactulose Fermentation Has No Impact on Glucagon-like Peptide-1 and Peptide-YY Secretion in Healthy Young Men. J Clin Endocrinol Metab. 2022 Jan 1;107(1):77-87. doi: 10.1210/clinem/dgab666.
Other Identifiers
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CBC-COLON-18
Identifier Type: -
Identifier Source: org_study_id
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