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OpenTrials
Completed

NCT Number: NCT02747472

GIP Receptor Antagonist Studies in Humans

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

Completed

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Key information

Conditions

Glucose Metabolism

Age range

20 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Diabetes Research

Copenhagen, Gentofte, 2900, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GIP-A

Drug

GIP receptor antagonist

GIP(1-42)

Drug

GIP receptor agonist

Saline

Other

Placebo

Primary outcomes

  1. Insulin levels

    Time frame: 65 minutes

    Serum-insulin AUC (area under the curve for hyperglycemic clamp period)

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Acronym: GA-1

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2016
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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