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

Blood Flow Clinical Trial

— GA-17  

Official title:

The Role of the Intestinal Hormones Glucose-dependent Insulinotropic Polypeptide (GIP) and Glucagon-like Peptide 2 (GLP-2) in Postprandial Splanchnic Blood Flow Distribution and Metabolism in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05391581
• Other study ID #: GA-17
• Status: Completed
• Phase: N/A
• Start date: January 13, 2022
• Est. completion date: February 7, 2023

Study information

• Verified date: December 2023
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow

Intervention

Other:
• GIPR antagonist / study tool
Selective antagonist of the GIPR, GIP(3-30)NH2
• GLP-2R antagonist / study tool
Selective antagonist of the GLP-2R, GLP-2(3-33)
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Redistribution of splanchnic blood flow (functional MRI)	Flow in mesenteric superior artery	90 minutes
Secondary	GIP levels	Blood sample (pmol/L)	90 minutes
Secondary	GLP-2 levels	Blood sample (pmol/L)	90 minutes
Secondary	GIP(3-30)NH2 levels	Blood sample (nmol/L)	90 minutes
Secondary	GLP-2(1-33) levels	Blood sample (nmol/L)	90 minutes
Secondary	CTX (bone resorption marker)	Blood sample	90 minutes
Secondary	P1NP (bone formation marker)	Blood sample	90 minutes
Secondary	Glucose	Blood sample (mmol/L)	90 minutes
Secondary	C-peptide	Blood sample (pmol/L)	90 minutes
Secondary	Insulin	Blood sample (pmol/L)	90 minutes
Secondary	Glucagon	Blood sample (pmol/L)	90 minutes
Secondary	Heart rate	Beats/minute	90 minutes
Secondary	Flow in coeliac trunk	Functional MRI estimated blood flow	90 minutes
Secondary	Flow in hepatic artery	Functional MRI estimated blood flow	90 minutes
Secondary	Flow in portal vein	Functional MRI estimated blood flow	90 minutes
Secondary	Liver oxygen content	Functional MRI estimated oxygenation	90 minutes