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Completed

NCT Number: NCT03013296

Delinieation of GIP's Effects During a Meal in Humans Using GIP Receptor Antagonisation (GA-4)

Delinieation of GIP's effects during a meal in humans using GIP receptor antagonisation.

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Key information

Conditions

Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 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 role of GIPR signalling in postprandial physiology, including lipid, bone and glucose homeostasis, using a naturally occurring GIP fragment, which antagonises the GIPR.

Twelve healthy men (age 18-70 years, BMI 19-27 kg/m2) with normal kidney and liver parameters and haemoglobin levels and no first-degree relatives with type 2 diabetes will be included in a randomised, double-blinded, placebo-controlled cross-over study. Study consists of four study days with concomitant infusions of A) GIP-A, B) GLP-1 receptor antagonist Exendin[9-39], C) GIP-A + Exendin[9-39], 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 > 27, first degree relatives with Type 2 Diabetes

Treatment and study plan

GIP-A

Other

GIP-A

Placebo

Other

Placebo

GLP-1 receptor antagonist Exendin[9-39]

Other

Exendin[9-39]

Other names: Ex(9-39)

GIP-A + Exendin[9-39]

Other

GIP-A + Exendin[9-39]

Primary outcomes

  1. C-peptide levels

    Time frame: 180 minutes

    Serum C-peptide AUC. Primary outcome changed during the inclusion period (original = insulin levels) due to risk of misinterpretation/diverse hepatic insulin extraction).

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Collaborators

  • University of Copenhagen

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jan 6, 2017
Registry last updated
Jun 4, 2019

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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