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

University Hospital, Gentofte, Copenhagen

Status: Completed

Conditions: Glucose Metabolism Disorders

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03013296

UHG-CFD-GIPANTA-4

Details and patient eligibility

About

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

Full description

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).

Enrollment: 12 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, BMI > 27, first degree relatives with Type 2 Diabetes

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 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]