GIP Receptor Antagonist Studies in Humans (GA-1)

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

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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