Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist

Not Applicable

Completed

• Conditions: Glucose Metabolism Disorders
• Interventions: Other: GIP-A; Other: GIP-A + Exendin[9-39]; Other: Placebo; Other: GLP-1 receptor antagonist Exendin[9-39]

• Registration Number: NCT03133741
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.

Detailed Description

Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.

Eighteen healthy men (age 18-70 years, BMI 19-35 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin\[9-39\], C) GIP-A + Exendin\[9-39\], or D) saline (placebo).

Study Timeline

• Study Start: 2017-03-01
• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-04-25
• Study First Posted: 2017-04-28
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-30
• Last Update Posted: 2017-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

• Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria

• Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
GIP-A	GIP-A	Infusion of GIP-A alone as study tool.
GIP-A + Exendin[9-39]	GIP-A + Exendin[9-39]	Infusion of GIP-A + GLP-1 receptor antagonist Exendin\[9-39\] together as study tools.
Placebo	Placebo	Saline
GLP-1 receptor antagonist Exendin[9-39]	GLP-1 receptor antagonist Exendin[9-39]	Infusion of GLP-1 receptor antagonist Exendin\[9-39\] alone as study tool.

Primary Outcome Measures

Name	Time	Method
Insulin levels	240 minutes	Serum insulin AUC (area under the curve)

Trial Locations

Locations (1)

Center for Diabetes Research; 🇩🇰 Gentofte, Copenhagen, Denmark