The Role of GIP in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Patients With Type 2 Diabetes (GA-17b)

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.

Study Overview

• Status: Completed
• Conditions: Blood Flow
• Intervention / Treatment: Other: Saline / placebo; Other: GIPR antagonist / study tool

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Rigshospitalet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Saline and oral water (SAL-WAT); Saline infusion, oral water ingestion	Other: Saline / placebo; NaCl (9 mg/ml)
Active Comparator: Saline infusion and oral glucose ingestion (SAL-GLU); Saline infusion, oral glucose ingestion	Other: Saline / placebo; NaCl (9 mg/ml)
Experimental: GIP(3-30)NH2 infusion and oral water ingestion (GIA-WAT); GIPR antagonist infusion, oral water ingestion	Other: GIPR antagonist / study tool; GIP(3-30)NH2
Experimental: GIP(3-30)NH2 infusion and oral glucose ingestion (GIA-GLU); GIPR antagonist infusion, oral glucose ingestion	Other: GIPR antagonist / study tool; GIP(3-30)NH2

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): March 16, 2026
• Study Completion (Actual): March 16, 2026

Study Registration Dates

• First Submitted: May 6, 2024
• First Submitted That Met QC Criteria: May 17, 2024
• First Posted (Actual): May 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Type 2 diabetes; GIP; Physiology; Gut hormones
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: GA-17b

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Will share upon requests

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No