Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)

Not Applicable

Completed

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

• Registration Number: NCT03013296
• Lead Sponsor: University Hospital, Gentofte, Copenhagen

Brief Summary

Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.

Detailed Description

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

Twelve healthy men (age 18-70 years, BMI 19-27 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: 2016-10
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-05
• Study First Posted: 2017-01-06
• Primary Completion: 2017-07
• Study Completion: 2018-09
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

• Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria

• Medication, Diabetes type 1 or 2, BMI > 27, first degree relatives with Type 2 Diabetes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
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.
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.
Placebo	Placebo	Saline
GIP-A	GIP-A	Infusion of GIP-A alone as study tool.

Primary Outcome Measures

Name	Time	Method
C-peptide levels	180 minutes	Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).

Trial Locations

Locations (1)

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