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Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist

NCT ID: NCT03133741

Last Updated: 2017-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2017-07-01

Brief Summary

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Delinieation of GIP's effects during an oral glucose tolerance test (OGTT) in humans using GIP receptor antagonisation.

Detailed Description

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Aim: To evaluate the role of GIPR signalling in postprandial physiology, including bone and glucose homeostasis, using a naturally occurring GIP fragment (GIP-A), which antagonises the GIPR.

Eighteen healthy men (age 18-70 years, BMI 19-35 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).

Conditions

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Glucose Metabolism Disorders

Keywords

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GIP GIP receptor antagonist

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Saline

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Saline (9mg/mL)

GIP-A

Infusion of GIP-A alone as study tool.

Group Type OTHER

GIP-A

Intervention Type OTHER

GIP-A (GIP receptor antagonist)

GLP-1 receptor antagonist Exendin[9-39]

Infusion of GLP-1 receptor antagonist Exendin\[9-39\] alone as study tool.

Group Type OTHER

GLP-1 receptor antagonist Exendin[9-39]

Intervention Type OTHER

Exendin\[9-39\]

GIP-A + Exendin[9-39]

Infusion of GIP-A + GLP-1 receptor antagonist Exendin\[9-39\] together as study tools.

Group Type OTHER

GIP-A + Exendin[9-39]

Intervention Type OTHER

GIP receptor antagonist + GLP-1 receptor antagonist

Interventions

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GIP-A

GIP-A (GIP receptor antagonist)

Intervention Type OTHER

GLP-1 receptor antagonist Exendin[9-39]

Exendin\[9-39\]

Intervention Type OTHER

Placebo

Saline (9mg/mL)

Intervention Type OTHER

GIP-A + Exendin[9-39]

GIP receptor antagonist + GLP-1 receptor antagonist

Intervention Type OTHER

Other Intervention Names

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EX(9-39) Saline

Eligibility Criteria

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Inclusion Criteria

* Normal kidney function, liver function and hemoglobin levels.

Exclusion Criteria

* Medication, Diabetes type 1 or 2, first degree relatives with Diabetes type 2
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Lærke Smidt Gasbjerg

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Filip K Knop, MD, PhD

Role: STUDY_DIRECTOR

UHGentofte, Center for Diabetes Research

Locations

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Center for Diabetes Research

Gentofte Municipality, Copenhagen, Denmark

Site Status

Countries

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Denmark

References

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Helsted MM, Gasbjerg LS, Lanng AR, Bergmann NC, Stensen S, Hartmann B, Christensen MB, Holst JJ, Vilsboll T, Rosenkilde MM, Knop FK. The role of endogenous GIP and GLP-1 in postprandial bone homeostasis. Bone. 2020 Nov;140:115553. doi: 10.1016/j.bone.2020.115553. Epub 2020 Jul 27.

Reference Type DERIVED
PMID: 32730920 (View on PubMed)

Gasbjerg LS, Helsted MM, Hartmann B, Jensen MH, Gabe MBN, Sparre-Ulrich AH, Veedfald S, Stensen S, Lanng AR, Bergmann NC, Christensen MB, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. Separate and Combined Glucometabolic Effects of Endogenous Glucose-Dependent Insulinotropic Polypeptide and Glucagon-like Peptide 1 in Healthy Individuals. Diabetes. 2019 May;68(5):906-917. doi: 10.2337/db18-1123. Epub 2019 Jan 9.

Reference Type DERIVED
PMID: 30626611 (View on PubMed)

Other Identifiers

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UHG-CFD-GIPANTA-3

Identifier Type: -

Identifier Source: org_study_id