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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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