GIP Receptor Antagonist Studies in Humans (GA-1)

April 25, 2017 updated by: Lærke Smidt Gasbjerg, University Hospital, Gentofte, Copenhagen

Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans

Antagonizing GIP effects during hyperglycaemia in healthy subjects and measurements of insulin secretion.

Study Overview

Status

Completed

Conditions

Detailed Description

Aim: To evaluate the GIP receptor antagonizing effect of peptide-based competitive GIP receptor antagonist GIP-A (vs. saline (placebo)) in 10 healthy subjects during 1 hour hyperglycaemic clamps with and without concomitant iv infusion of GIP[1-42]. The intention is to establish GIP-A as a tool to eliminate glucose-dependent insulinotropic GIP signalling.

The study consists of four experimental days (A-D) with assessment of beta cell function during 12 mM-hyperglycaemic clamps with concomitant infusions of A) GIP[1-42], B) GIP-A, C) GIP[1-42] + GIP-A, or D) saline (placebo).

Study Type

Interventional

Enrollment (Actual)

10

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

    • 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

20 years to 30 years (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, BMI > 25, 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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Infusion of saline
Placebo
ACTIVE_COMPARATOR: GIP(1-42)
Infusion of agonist, GIP(1-42)
GIP receptor agonist
EXPERIMENTAL: GIP-A
Infusion of GIP-A alone
GIP receptor antagonist
EXPERIMENTAL: GIP-A + GIP(1-42)
Infusion of GIP-A and GIP(1-42)
GIP receptor agonist
GIP receptor antagonist

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin levels
Time Frame: 65 minutes
Serum-insulin AUC (area under the curve for hyperglycemic clamp period)
65 minutes

Collaborators and Investigators

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

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.

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

April 1, 2016

Primary Completion (ACTUAL)

July 1, 2016

Study Completion (ACTUAL)

July 1, 2016

Study Registration Dates

First Submitted

April 19, 2016

First Submitted That Met QC Criteria

April 19, 2016

First Posted (ESTIMATE)

April 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • UHG-CFD-GIPANTA-1

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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