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

NCT ID: NCT05391581

Last Updated: 2023-12-26

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-13

Study Completion Date

2023-02-07

Brief Summary

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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.

Detailed Description

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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

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Blood Flow

Keywords

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Gut hormones GIP GLP-2 Physiology

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single blind, placebo controlled, randomized, crossover study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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SAL-WAT

Saline infusion, saline injection, water ingestion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline

SAL-GLU

Saline infusion, saline injection, glucose ingestion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Saline

SAL-GIP

Saline infusion, GIP injection, water ingestion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Saline

SAL-GLP-2

Saline infusion, GLP-2 injection, water ingestion

Group Type ACTIVE_COMPARATOR

Placebo

Intervention Type OTHER

Saline

GIA-WAT

GIPR antagonist infusion, saline injection, water ingestion

Group Type EXPERIMENTAL

GIPR antagonist / study tool

Intervention Type OTHER

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

Placebo

Intervention Type OTHER

Saline

GIA-GLU

GIPR antagonist infusion, saline injection, glucose ingestion

Group Type EXPERIMENTAL

GIPR antagonist / study tool

Intervention Type OTHER

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

GLA-WAT

GLP-2R antagonist infusion, saline injection, water ingestion

Group Type EXPERIMENTAL

GLP-2R antagonist / study tool

Intervention Type OTHER

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

Placebo

Intervention Type OTHER

Saline

GLA-GLU

GLP-2R antagonist infusion, saline injection, glucose ingestion

Group Type EXPERIMENTAL

GLP-2R antagonist / study tool

Intervention Type OTHER

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

Interventions

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GIPR antagonist / study tool

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

Intervention Type OTHER

GLP-2R antagonist / study tool

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

Intervention Type OTHER

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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GA-17

Identifier Type: -

Identifier Source: org_study_id