GIP Receptor Antagonist Studies in Humans (GA-1)

U

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Glucose Metabolism

Treatments

Drug: GIP-A
Drug: GIP(1-42)
Other: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT02747472
UHG-CFD-GIPANTA-1

Details and patient eligibility

About

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

Full 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).

Enrollment

10 patients

Sex

Male

Ages

20 to 30 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

10 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Infusion of saline
Treatment:
Other: Saline
GIP(1-42)
Active Comparator group
Description:
Infusion of agonist, GIP(1-42)
Treatment:
Drug: GIP(1-42)
GIP-A
Experimental group
Description:
Infusion of GIP-A alone
Treatment:
Drug: GIP-A
GIP-A + GIP(1-42)
Experimental group
Description:
Infusion of GIP-A and GIP(1-42)
Treatment:
Drug: GIP(1-42)
Drug: GIP-A

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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