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

Not Applicable

Recruiting

• Conditions: Blood Flow
• Interventions: Other: Saline / placebo; Other: GIPR antagonist / study tool

• Registration Number: NCT06426823
• Lead Sponsor: University of Copenhagen

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 Timeline

• Study Start: 2023-11-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-06
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2024-07
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline and oral water (SAL-WAT)	Saline / placebo	Saline infusion, oral water ingestion
Saline infusion and oral glucose ingestion (SAL-GLU)	Saline / placebo	Saline infusion, oral glucose ingestion
GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT)	GIPR antagonist / study tool	GIPR antagonist infusion, oral water ingestion
GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU)	GIPR antagonist / study tool	GIPR antagonist infusion, oral glucose ingestion

Primary Outcome Measures

Name	Time	Method
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (functional MRI)	80 minutes	Measued with phase-contrast MRI in ml/min

Secondary Outcome Measures

Name	Time	Method
GIP(3-30)NH2 levels	80 minutes	Radioimmuno assay on plasma blood sample (nmol/L)
Glucose	80 minutes	Bedside measurement of whole blood sample (mmol/L)
C-peptide	80 minutes	Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)
Glucagon	80 minutes	Radioimmuno assay on plasma blood samples (pmol/L)
Insulin	80 minutes	Electrochemiluminescence immunoassay of plasma blood sample (pmol/L)
Blood flow in portal vein	80 minutes	Measued with phase-contrast MRI in ml/min
Blood flow in hepatic artery	80 minutes	Measued with phase-contrast MRI in ml/min
Blood flow in coeliac trunc	80 minutes	Measued with phase-contrast MRI in ml/min
GIP levels	80 minutes	Radioimmuno assay on plasma blood sample (pmol/L)

Trial Locations

Locations (1)

Rigshospitalet; 🇩🇰 Copenhagen, Denmark