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

June 1, 2019 updated by: Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen
Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Gentofte
      • Copenhagen, Gentofte, Denmark, 2900
        • Center for diabetes research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Saline
Other: Placebo
Placebo
Other: GIP-A
Infusion of GIP-A alone as study tool.
Other: GIP-A
GIP-A
Other: GLP-1 receptor antagonist Exendin[9-39]
Infusion of GLP-1 receptor antagonist Exendin[9-39] alone as study tool.
Other: GLP-1 receptor antagonist Exendin[9-39]
Exendin[9-39]
Other Names:
  • Ex(9-39)
Other: GIP-A + Exendin[9-39]
Infusion of GIP-A + GLP-1 receptor antagonist Exendin[9-39] together as study tools.
Other: GIP-A + Exendin[9-39]
GIP-A + Exendin[9-39]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C-peptide levels
Time Frame: 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).
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Collaborators

University of Copenhagen

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

January 3, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Actual)

June 4, 2019

Last Update Submitted That Met QC Criteria

June 1, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHG-CFD-GIPANTA-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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