Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)

October 30, 2017 updated by: Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen

Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)

Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) 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 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 Type

Interventional

Enrollment (Actual)

18

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
    • Copenhagen
      • Gentofte, Copenhagen, 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

Yes

Genders Eligible for Study

Male

Description

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 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
Saline (9mg/mL)
Other Names:
  • Saline
Other: GIP-A
Infusion of GIP-A alone as study tool.
Other: GIP-A
GIP-A (GIP receptor antagonist)
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 receptor antagonist + GLP-1 receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin levels
Time Frame: 240 minutes
Serum insulin AUC (area under the curve)
240 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

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 (Actual)

March 1, 2017

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

April 25, 2017

First Submitted That Met QC Criteria

April 25, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

November 1, 2017

Last Update Submitted That Met QC Criteria

October 30, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHG-CFD-GIPANTA-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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