Skip to main content
OpenTrials
Completed

NCT Number: NCT05391581

The Role of GIP and GLP-2 in Postprandial Splanchnic Blood Flow Distribution and Metabolism

This project will describe the mechanisms of action and the relative contributions of GIP and GLP-2 to changes in gastrointestinal blood flow induced by oral glucose, exogenous GIP and GLP-2 infusions, and endogenous GIP and GLP-2 with the use of two novel receptor antagonists GIP(3-30)NH2 and GLP-2(3-33) in healthy individuals.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2200, Denmark

About this study

Each participant will attend eight independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo), subcutaneous injection (hormon/placebo) and oral ingestion (glucose/water). On experimental day A-C, an intravenous infusion of saline, GIP(3-30)NH2, or GLP-2(3-33), respectively, starts at time point -20 minutes. On experimental day D-F, the same infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes. On experimental days G-H, a subcutaneous injection of either GIP or GLP-2 at time point 0 minutes is performed (positive control) during saline infusion and oral water ingestion.

MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines, pancreas, and bones.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No first degree relatives with diabetes
  • BMI 20-27 kg/m2

Exclusion criteria

  • Not MRI-compatible implants
  • Claustrophobia
  • Diabetes
  • Abnormal kidney or liver function
  • Anemia
  • Planned weight loss or change in diet
  • Hypertension
  • Other conditions that could be expected to affect the primary or secondary outcomes

Treatment and study plan

GIPR antagonist / study tool

Other

Selective antagonist of the GIPR, GIP(3-30)NH2

GLP-2R antagonist / study tool

Other

Selective antagonist of the GLP-2R, GLP-2(3-33)

Placebo

Other

Saline

Primary outcomes

  1. Redistribution of splanchnic blood flow (functional MRI)

    Time frame: 90 minutes

    Flow in mesenteric superior artery

Secondary outcomes

  1. GIP levels

    Time frame: 90 minutes

    Blood sample (pmol/L)

  2. GLP-2 levels

    Time frame: 90 minutes

    Blood sample (pmol/L)

  3. GIP(3-30)NH2 levels

    Time frame: 90 minutes

    Blood sample (nmol/L)

  4. GLP-2(1-33) levels

    Time frame: 90 minutes

    Blood sample (nmol/L)

  5. CTX (bone resorption marker)

    Time frame: 90 minutes

    Blood sample

  6. P1NP (bone formation marker)

    Time frame: 90 minutes

    Blood sample

  7. Glucose

    Time frame: 90 minutes

    Blood sample (mmol/L)

  8. C-peptide

    Time frame: 90 minutes

    Blood sample (pmol/L)

  9. Insulin

    Time frame: 90 minutes

    Blood sample (pmol/L)

  10. Glucagon

    Time frame: 90 minutes

    Blood sample (pmol/L)

  11. Heart rate

    Time frame: 90 minutes

    Beats/minute

  12. Flow in coeliac trunk

    Time frame: 90 minutes

    Functional MRI estimated blood flow

  13. Flow in hepatic artery

    Time frame: 90 minutes

    Functional MRI estimated blood flow

  14. Flow in portal vein

    Time frame: 90 minutes

    Functional MRI estimated blood flow

  15. Liver oxygen content

    Time frame: 90 minutes

    Functional MRI estimated oxygenation

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

The Role of the Intestinal Hormones Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-like Peptide 2 (GLP-2) in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Humans

Acronym: GA-17

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 26, 2022
Registry last updated
Dec 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.