NCT04159181

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable healthy

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

July 16, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 12, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2020

Completed
Last Updated

November 12, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

July 9, 2018

Last Update Submit

November 7, 2019

Conditions

Healthy

Keywords

ColonPYYsGLP-1Gut peptidesFermentationLactulosehuman

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    -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

    -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

    -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

    -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

  • +1 more secondary outcomes

Study Arms (3)

Day A

EXPERIMENTAL

After an overnight fast participants will receive an oral solution of lactulose (20g lactulose/200mL water).

Other: Lactulose

Day B

EXPERIMENTAL

After an overnight fast participants will drink 200mL of water

Other: Placebo (water)

Day C

EXPERIMENTAL

After an overnight fast and an evacuation of the colonic content, participants will receive an oral solution of lactulose (20g lactulose/200mL water).

Other: LactuloseOther: Picoprep

Interventions

LactuloseOTHER

Oral solution lactulose (20g lactulose/200mL water).

Day ADay C
PicoprepOTHER

Cathartic to accomplish an evacuation of the colonic content.

Day C
Placebo (water)OTHER

oral administration of Water (200mL).

Day B

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy young men (self-reported)
  • BMI between 18,5-24,9 kg/m\^2

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Copenhagen

Copenhagen, Capital, 2200, Denmark

Location

Hvidovre University Hospital

Hvidovre, Capital, 2650, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 34508600DERIVED

MeSH Terms

Interventions

Lactulosepicosulfate sodiumWater

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugarsHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Jens J Holst, MD, Dr.med.

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

July 9, 2018

First Posted

November 12, 2019

Study Start

July 16, 2018

Primary Completion

July 31, 2019

Study Completion

July 1, 2020

Last Updated

November 12, 2019

Record last verified: 2019-11

Locations

DK(2)