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

Incretin Effect Clinical Trial

— H-21044858  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06194955
• Other study ID #: H-21044858
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2023
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: University of Copenhagen
• Contact: Lærke S Gasbjerg, MD, PhD
• Phone: +45 35322626
• Email: lsg[@]sund.ku.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2027
• Est. primary completion date: December 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Incretin Effect

Intervention

Drug:
• GIP(1-42)
Infusion
• GLP-1
Infusion
• GLP-2
Infusion

Other:
• Placebo
Saline

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research, Gentofte Hospital	Hellerup

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Gentofte Hospital, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	For GIP- and GLP-1 receptor variants: Insulinotropic effect (C-peptide)	Blood sample	240 minutes
Primary	For GLP-2 receptor variants: CTX (bone resorption marker)	Blood sample	120 minutes
Secondary	GIP levels	Blood sample	240 minutes
Secondary	GLP-1 levels	Blood sample	240 minutes
Secondary	GLP-2 levels	Blood sample	240 minutes
Secondary	CTX (bone resorption marker)	Blood sample	240 minutes
Secondary	P1NP (bone formation marker)	Blood Sample	240 minutes
Secondary	Heart rate	Beats/minute	240 minutes
Secondary	Insulin	Blood sample	240 minutes
Secondary	Glucagon	Blood sample	240 minutes