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Clinical Trials/NCT06426823
NCT06426823CompletedNot Applicable

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

University of Copenhagen1 site in 1 country10 target enrollmentStarted: November 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
10
Locations
1
Primary Endpoint
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Single (Participant)

Eligibility Criteria

Ages
20 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • Planned weight loss or change in diet
  • Hypertension
  • Other conditions that could be expected to affect the primary or secondary outcomes

Arms & Interventions

Saline and oral water (SAL-WAT)

Placebo Comparator

Saline infusion, oral water ingestion

Intervention: Saline / placebo (Other)

Saline infusion and oral glucose ingestion (SAL-GLU)

Active Comparator

Saline infusion, oral glucose ingestion

Intervention: Saline / placebo (Other)

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

Experimental

GIPR antagonist infusion, oral water ingestion

Intervention: GIPR antagonist / study tool (Other)

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

Experimental

GIPR antagonist infusion, oral glucose ingestion

Intervention: GIPR antagonist / study tool (Other)

Outcomes

Primary Outcomes

Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)

Time Frame: 80 minutes

Measued with phase-contrast MRI in ml/min

Secondary Outcomes

  • GIP(3-30)NH2 levels(80 minutes)
  • Glucose(80 minutes)
  • C-peptide(80 minutes)
  • Glucagon(80 minutes)
  • Insulin(80 minutes)
  • Blood flow in portal vein(80 minutes)
  • Blood flow in hepatic artery(80 minutes)
  • Blood flow in coeliac trunc(80 minutes)
  • GIP levels(80 minutes)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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