GA-1: GIP Receptor Antagonist Studies in Humans

• Sponsor: University Hospital, Gentofte, Copenhagen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02747472
• Collaborator: University of Copenhagen (Other)
• Enrollment: 10
• Location: 1
• Arms: 4
• Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Glucose Metabolism	Drug: GIP-A; Drug: GIP(1-42); Other: Saline	N/A

Detailed 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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo Infusion of saline	Other: Saline; Placebo
Active Comparator: GIP(1-42) Infusion of agonist, GIP(1-42)	Drug: GIP(1-42); GIP receptor agonist
Experimental: GIP-A Infusion of GIP-A alone	Drug: GIP-A; GIP receptor antagonist
Experimental: GIP-A + GIP(1-42) Infusion of GIP-A and GIP(1-42)	Drug: GIP-A; GIP receptor antagonist; Drug: GIP(1-42); GIP receptor agonist

Outcome Measures

Primary Outcome Measures

1. Insulin levels [65 minutes]

   Serum-insulin AUC (area under the curve for hyperglycemic clamp period)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 30 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center for Diabetes Research	Copenhagen	Gentofte	Denmark	2900

Sponsors and Collaborators

• University Hospital, Gentofte, Copenhagen
• University of Copenhagen

Investigators

• Study Director: Filip K Knop, MD, PhD, UHGentofte, Center for Diabetes Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lærke Smidt Gasbjerg, MD, University Hospital, Gentofte, Copenhagen
• ClinicalTrials.gov Identifier: NCT02747472
• Other Study ID Numbers: UHG-CFD-GIPANTA-1
• First Posted: Apr 21, 2016
• Last Update Posted: Apr 27, 2017
• Last Verified: Apr 1, 2017

• Keywords provided by Lærke Smidt Gasbjerg, MD, University Hospital, Gentofte, Copenhagen: GIP; GIP receptor antagonist

Study Results

No Results Posted as of Apr 27, 2017