GIP Receptor Antagonist Studies in Humans

NCT ID: NCT02747472

Last Updated: 2017-04-27

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

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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).

Conditions

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Glucose Metabolism

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

Infusion of saline

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Placebo

GIP(1-42)

Infusion of agonist, GIP(1-42)

Group Type ACTIVE_COMPARATOR

GIP(1-42)

Intervention Type DRUG

GIP receptor agonist

GIP-A

Infusion of GIP-A alone

Group Type EXPERIMENTAL

GIP-A

Intervention Type DRUG

GIP receptor antagonist

GIP-A + GIP(1-42)

Infusion of GIP-A and GIP(1-42)

Group Type EXPERIMENTAL

GIP-A

Intervention Type DRUG

GIP receptor antagonist

GIP(1-42)

Intervention Type DRUG

GIP receptor agonist

Interventions

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GIP-A

GIP receptor antagonist

Intervention Type DRUG

GIP(1-42)

GIP receptor agonist

Intervention Type DRUG

Saline

Placebo

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

30 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

Copenhagen, Gentofte, Denmark

Site Status

Countries

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Denmark

References

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Gasbjerg LS, Christensen MB, Hartmann B, Lanng AR, Sparre-Ulrich AH, Gabe MBN, Dela F, Vilsboll T, Holst JJ, Rosenkilde MM, Knop FK. GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb;61(2):413-423. doi: 10.1007/s00125-017-4447-4. Epub 2017 Sep 25.

Reference Type DERIVED
PMID: 28948296 (View on PubMed)

Other Identifiers

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UHG-CFD-GIPANTA-1

Identifier Type: -

Identifier Source: org_study_id

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