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

Blood Flow Clinical Trial

— GA-17b  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426823
• Other study ID #: GA-17b
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: Lærke S Gasbjerg, MD PhD
• Phone: 25346894
• Email: lsg[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Flow
• Diabetes Mellitus, Type 2

Intervention

Other:
• Saline / placebo
NaCl (9 mg/ml)
• GIPR antagonist / study tool
GIP(3-30)NH2

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