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NCT03013296 Clinical Trial

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

Glucose Metabolism Disorders Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03013296
Other study ID # UHG-CFD-GIPANTA-4
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date September 2018

Study information
Verified date June 2019
Source University Hospital, Gentofte, Copenhagen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date September 2018
Est. primary completion date July 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• GIP-A
GIP-A
• Placebo
Placebo
• GLP-1 receptor antagonist Exendin[9-39]
Exendin[9-39]
• GIP-A + Exendin[9-39]
GIP-A + Exendin[9-39]

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