GIP Receptor Antagonist Studies in Humans

Glucose Metabolism Clinical Trial

— GA-1  

Official title:

Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02747472
• Other study ID #: UHG-CFD-GIPANTA-1
• Status: Completed
• Phase: N/A
• First received: April 19, 2016
• Last updated: April 25, 2017
• Start date: April 2016
• Est. completion date: July 2016

Study information

• Verified date: April 2017
• Source: University Hospital, Gentofte, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Description:

Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 30 Years

Eligibility

Inclusion Criteria:

• Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria:

• Medication, Diabetes type 1 or 2, BMI > 25, first degree relatives with Type 2 Diabetes

Related Conditions & MeSH terms

• Glucose Metabolism

Intervention

Drug:
• GIP-A
GIP receptor antagonist
• GIP(1-42)
GIP receptor agonist

Other:
• Saline
Placebo

Locations

Country	Name	City	State
Denmark	Center for Diabetes Research	Copenhagen	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin levels	Serum-insulin AUC (area under the curve for hyperglycemic clamp period)	65 minutes