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Inhibition of the Endogenous GIP Response With a GIP Receptor Antagonist (GA-3)

U

University Hospital, Gentofte, Copenhagen

Status

Completed

Conditions

Glucose Metabolism Disorders

Treatments

Other: GLP-1 receptor antagonist Exendin[9-39]
Other: GIP-A
Other: Placebo
Other: GIP-A + Exendin[9-39]

Study type

Interventional

Funder types

Other

Identifiers

NCT03133741
UHG-CFD-GIPANTA-3

Details and patient eligibility

About

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

Full description

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).

Enrollment

18 patients

Sex

Male

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

18 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Saline
Treatment:
Other: Placebo
GIP-A
Other group
Description:
Infusion of GIP-A alone as study tool.
Treatment:
Other: GIP-A
GLP-1 receptor antagonist Exendin[9-39]
Other group
Description:
Infusion of GLP-1 receptor antagonist Exendin\[9-39\] alone as study tool.
Treatment:
Other: GLP-1 receptor antagonist Exendin[9-39]
GIP-A + Exendin[9-39]
Other group
Description:
Infusion of GIP-A + GLP-1 receptor antagonist Exendin\[9-39\] together as study tools.
Treatment:
Other: GIP-A + Exendin[9-39]

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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