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Blood FlowGA-17NCT05391581

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

A study testing GIPR antagonist / study tool and GLP-2R antagonist / study tool in people with Blood Flow, run by University of Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for
Blood Flow
What is being tested?
GIPR antagonist / study tool and GLP-2R antagonist / study tool
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
1 siteDenmark
Study dates
13 Jan 2022to 7 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 70 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Rigshospitalet

    Copenhagen, 2200

Other trials in Denmark

About this study

Official 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

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.

Read the detailed description

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.

Conditions
Blood Flow
Being tested
GIPR antagonist / study tool, GLP-2R antagonist / study tool, Placebo
Keywords
Gut hormones, GIP, GLP-2, Physiology

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GIPR antagonist / study toolOther

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

  • GLP-2R antagonist / study toolOther

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

  • PlaceboOther

    Saline

Study groups in NCT05391581
Study groupRoleWhat they receive
SAL-WATPlacebo comparatorSaline infusion, saline injection, water ingestion
Receives: Other: Placebo
SAL-GLUActive comparatorSaline infusion, saline injection, glucose ingestion
Receives: Other: Placebo
SAL-GIPActive comparatorSaline infusion, GIP injection, water ingestion
Receives: Other: Placebo
SAL-GLP-2Active comparatorSaline infusion, GLP-2 injection, water ingestion
Receives: Other: Placebo
GIA-WATExperimentalGIPR antagonist infusion, saline injection, water ingestion
Receives: Other: GIPR antagonist / study tool; Other: Placebo
GIA-GLUExperimentalGIPR antagonist infusion, saline injection, glucose ingestion
Receives: Other: GIPR antagonist / study tool
GLA-WATExperimentalGLP-2R antagonist infusion, saline injection, water ingestion
Receives: Other: GLP-2R antagonist / study tool; Other: Placebo
GLA-GLUExperimentalGLP-2R antagonist infusion, saline injection, glucose ingestion
Receives: Other: GLP-2R antagonist / study tool

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Redistribution of splanchnic blood flow (functional MRI)

    Flow in mesenteric superior artery

    Measured: 90 minutes

Secondary outcomes (15)

  1. GIP levels

    Blood sample (pmol/L)

    Measured: 90 minutes

  2. GLP-2 levels

    Blood sample (pmol/L)

    Measured: 90 minutes

  3. GIP(3-30)NH2 levels

    Blood sample (nmol/L)

    Measured: 90 minutes

  4. GLP-2(1-33) levels

    Blood sample (nmol/L)

    Measured: 90 minutes

  5. CTX (bone resorption marker)

    Blood sample

    Measured: 90 minutes

  6. P1NP (bone formation marker)

    Blood sample

    Measured: 90 minutes

  7. Glucose

    Blood sample (mmol/L)

    Measured: 90 minutes

  8. C-peptide

    Blood sample (pmol/L)

    Measured: 90 minutes

  9. Insulin

    Blood sample (pmol/L)

    Measured: 90 minutes

  10. Glucagon

    Blood sample (pmol/L)

    Measured: 90 minutes

  11. Heart rate

    Beats/minute

    Measured: 90 minutes

  12. Flow in coeliac trunk

    Functional MRI estimated blood flow

    Measured: 90 minutes

  13. Flow in hepatic artery

    Functional MRI estimated blood flow

    Measured: 90 minutes

  14. Flow in portal vein

    Functional MRI estimated blood flow

    Measured: 90 minutes

  15. Liver oxygen content

    Functional MRI estimated oxygenation

    Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2022
  2. Study start13 Jan 2022
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Single blind, placebo controlled, randomized, crossover study
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391581
Sponsor's protocol ID
GA-17
Acronym
GA-17
Status last verified
Dec 2023
First submitted
6 May 2022
Last updated
26 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Will share upon requests

Publications

  • Gasbjerg LS, Ostergaard FH, Rasmussen RS, Langberg LS, Nielsen SW, Alstrup L, Larsson TSW, Andersen UB, Larsson HBW, Asmar A, Haddock B, Vestergaard MB. Reproducibility of Splanchnic Blood Flow Measured Using Phase-Contrast MRI. NMR Biomed. 2026 Aug;39(8):e70348. doi: 10.1002/nbm.70348.

    PubMed 42373095

Questions about this trial

What is this clinical trial studying?

A study testing GIPR antagonist / study tool and GLP-2R antagonist / study tool in people with Blood Flow, run by University of Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Redistribution of splanchnic blood flow (functional MRI) (time frame: 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391581, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.

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