The Effect of GIP, GLP-1 and GLP-2 in Individuals With Genetically Altered Receptor Function

NCT ID: NCT06194955

Last Updated: 2024-05-07

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

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-04

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Participants with mutations in their GLP-1- and GIP receptor will attend five randomized experimental days, A1, A2, B, C and D. On day A1 an oral glucose tolerance test (OGTT) will be performed, and on day A2, an intravenous isoglycaemic glucose infusion (IIGI) will be performed. On experimental day B and C, the study participants will receive GLP-1 and GIP hormones, respectively, under stable glucose infusions and on experimental day D, they will receive infusion of salt water (placebo) under stable glucose infusion.

Participants with mutations in their GLP-2 receptor will attend three randomized experimental days, E, F and G. A mixed meal test (MMT) will be performed on day E, an infusion with GLP-2 during fasting blood glucose levels will be performed on day F, and infusion with salt water (placebo) during fasting blood glucose levels will be performed on day G.

Additionally, a DXA scan and arginine test will be performed on all study participants.

Conditions

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Incretin Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single-blind, randomized, crossover study
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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GIPR variant carriers

Inidividuals with GIPR variants: Determination of the incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.

Group Type ACTIVE_COMPARATOR

GIP(1-42)

Intervention Type DRUG

Infusion

GLP-1

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

GIPR variant carrier controls

Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp.

Group Type PLACEBO_COMPARATOR

GIP(1-42)

Intervention Type DRUG

Infusion

GLP-1

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

GLP-1R variant carrier

Individuals with GLP-1R variants: Determination of incretin effect, and the insulinotropic actions of GIP and GLP-1 infusions during hyperglycemic clamp

Group Type ACTIVE_COMPARATOR

GIP(1-42)

Intervention Type DRUG

Infusion

GLP-1

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

GLP-1R variant carrier controls

Healthy matched individuals: Determination of incretin effect, and the insulinotropic actions of to GIP and GLP-1 infusions during hyperglycemic clamp.

Group Type PLACEBO_COMPARATOR

GIP(1-42)

Intervention Type DRUG

Infusion

GLP-1

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

GLP-2R variant carrier

Individuals with GLP-2R variants: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels

Group Type ACTIVE_COMPARATOR

GLP-2

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

GLP-2R variant carrier control

Healthy matched individuals: Determination of bone resorption marker levels (CTX) and response to GLP-2 infusions during fasting blood glucose levels

Group Type PLACEBO_COMPARATOR

GLP-2

Intervention Type DRUG

Infusion

Placebo

Intervention Type OTHER

Saline

Interventions

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GIP(1-42)

Infusion

Intervention Type DRUG

GLP-1

Infusion

Intervention Type DRUG

GLP-2

Infusion

Intervention Type DRUG

Placebo

Saline

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gentofte Hospital, Denmark

UNKNOWN

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for Clinical Metabolic Research, Gentofte Hospital

Hellerup, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Lærke S Gasbjerg, MD, PhD

Role: CONTACT

+45 35322626

Sheyma Kizilkaya, MSc

Role: CONTACT

+45 40502056

Facility Contacts

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Lærke S Gasbjerg

Role: primary

Other Identifiers

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H-21044858

Identifier Type: -

Identifier Source: org_study_id

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