Clinical trial

The Effect of Glucose-dependent Insulinotropic Polypeptide (GIP), Glucagon-like Peptide-1 (GLP-1) and Glucagon-like Peptide-2 (GLP-2) in Individuals With Genetically Altered Receptor Function

NCT06194955

Name

H-21044858

Description

This project will characterize the physiological effect of the hormones, GIP-, GLP-1- and GLP-2 infusions in a group of individuals that are carriers of GIP-, GLP-1- and GLP-2 receptor gene variants, respectively.

Trial arms

Trial start

2023-01-04

Estimated PCD

2027-12-01

Trial end

2027-12-01

Status

Recruiting

Treatment

GIP(1-42)

Infusion

Arms:

GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls

GLP-1

Infusion

Arms:

GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls

GLP-2

Infusion

Arms:

GLP-2R variant carrier, GLP-2R variant carrier control

Placebo

Saline

Arms:

GIPR variant carrier controls, GIPR variant carriers, GLP-1R variant carrier, GLP-1R variant carrier controls, GLP-2R variant carrier, GLP-2R variant carrier control

Size

Primary endpoint

For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide)

240 minutes

For GLP-2 receptor variants: CTX (bone resorption marker)

120 minutes

Eligibility criteria

Inclusion Criteria: * BMI 19-35 kg/m2 Exclusion Criteria: * Treatment with medication or supplements that can not be discontinued for 12 hours * \>10 objects of alcohol weekly or abuse of narcotics * Liver disease (defined as ALAT and/or ASAT ≥ 2 x normal levels) * Decreased kidney function (creatine levels over reference interval) * Uncontrollable increased blood pressure (\> 140/90 mmHg) * Low blood percentage (hemoglobin \< 8.3 mmol/l) * Special diet or planned weight change during trial period * Other conditions that could be expected to affect the primary or secondary outcomes

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Single-blind, randomized, crossover study', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 60, 'type': 'ESTIMATED'}}

Updated at

2024-05-07

1 organization

3 products

1 indication

Organization

University of Copenhagen

Product

Indication

Product

Product