- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02747472
GIP Receptor Antagonist Studies in Humans (GA-1)
Involvement of Glucose-dependent Insulinotropic Polypeptide (GIP) in Human Physiology and Pathophysiology - Receptor Antagonist Studies in Humans
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Gentofte
-
Copenhagen, Gentofte, Denmark, 2900
- Center for diabetes research
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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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