The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes

NCT ID: NCT06426823

Last Updated: 2024-05-23

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

RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-12-31

Brief Summary

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This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with type 2 diabetes.

Detailed Description

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Each participant will attend four independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose/water): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The 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 two of the experimental days (with and without GIP(3-30)NH2).

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

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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Saline and oral water (SAL-WAT)

Saline infusion, oral water ingestion

Group Type PLACEBO_COMPARATOR

Saline / placebo

Intervention Type OTHER

NaCl (9 mg/ml)

Saline infusion and oral glucose ingestion (SAL-GLU)

Saline infusion, oral glucose ingestion

Group Type ACTIVE_COMPARATOR

Saline / placebo

Intervention Type OTHER

NaCl (9 mg/ml)

GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)

GIPR antagonist infusion, oral water ingestion

Group Type EXPERIMENTAL

GIPR antagonist / study tool

Intervention Type OTHER

GIP(3-30)NH2

GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)

GIPR antagonist infusion, oral glucose ingestion

Group Type EXPERIMENTAL

GIPR antagonist / study tool

Intervention Type OTHER

GIP(3-30)NH2

Interventions

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Saline / placebo

NaCl (9 mg/ml)

Intervention Type OTHER

GIPR antagonist / study tool

GIP(3-30)NH2

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Type 2 diabetes
* BMI 20-35 kg/m\^2
* Age 20-80

Exclusion Criteria

* Not MRI-compatible implants
* Claustrophobia
* 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

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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 RECRUITING

Countries

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Denmark

Central Contacts

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Lærke S Gasbjerg, MD PhD

Role: CONTACT

25346894 ext. +45

Rasmus S Rasmussen, Cand.scient.

Role: CONTACT

50534173 ext. +45

Facility Contacts

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Lærke S Gasbjerg

Role: primary

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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GA-17b

Identifier Type: -

Identifier Source: org_study_id

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