A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass

Diabetes Mellitus Clinical Trial

— Ver-A-image  

Official title:

A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615910
• Other study ID #: 20201013
• Status: Recruiting
• Phase: Phase 2
• Start date: July 1, 2021
• Est. completion date: July 1, 2025

Study information

• Verified date: December 2023
• Source: Radboud University Medical Center
• Contact: Marti Boss, PhD
• Phone: +31614542555
• Email: marti.boss[@]radboudumc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the trial is to measure pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for detection of intra-individual differences in beta cell mass before and after treatment with Verapamil.

Description:

The VER-A-T1D (Verapamil SR in adults with Type 1 Diabetes) study is an intervention study within the INNODIA project (an Innovative Medicines Initiative consortium (IMI-2), established through Horizon 2020 initiative of the European Union, involving academic, industry and charitable partners).

In the VER-A-T1D study, the effects of treatment of newly diagnosed patients with T1D with Verapamil will be evaluated. Verapamil appears to protect beta cell function, an effect that could in part be caused by protection against beta cell apoptosis. GLP-1 receptors are expressed in high densities in beta cells. Exendin, a GLP-1 receptor agonist, can be labeled with radionuclides and thus be utilized for visualization of beta cells in vivo by positron emission tomography (PET). This technology has been demonstrated to deliver quantitative information of the radiotracer uptake in the pancreas demonstrating a linear correlation with beta cell mass. In VER-A-T1D, we propose to measure beta cell mass at the time points of inclusion and at evaluation after 12 months. If verapamil protects beta cells against apoptosis, we expect that the uptake of the radiotracer will be higher at 12 months in comparison to the first measurement in the treatment group. The study will be a substudy to VER-A-T1D.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• • Have given written informed consent

• • Age =18 and <45 at consent

• • Must have a diagnosis of T1D of within 6 weeks duration at screening (date of the first insulin

• injection)

• • Must have at least one or more diabetes-related autoantibodies present at screening

• • Must have random C-peptide levels =200 pmol/L measured at screening

• • Be willing to comply with intensive diabetes management

Exclusion Criteria:

• Treatment with synthetic Exendin (Exenatide, Byetta®) or Dipeptidyl-Peptidase IV inhibitors (to exclude interferences with imaging, specifically mentioned although in principle part of exclusion criteria of VER-A-T1D)

• Renal disease defined as MDRD <40 ml/min/1.73 m2

• Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Radiation:
• 68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT

Locations

Country	Name	City	State
Austria	University of Vienna	Vienna
France	Assistance Publique hopitaux de Paris	Paris

Sponsors (5)

Lead Sponsor	Collaborator
Radboud University Medical Center	Assistance Publique - Hôpitaux de Paris, Bart's London, KU Leuven, Medical University of Vienna

Countries where clinical trial is conducted

Austria,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pancreatic 68Ga-exendin uptake	the total pancreatic uptake of 68Ga-NODAGA-exendin by PET/CT for determination of beta cell mass	Change from time of inclusion to 12 months into treatment
Secondary	Correlation of 68Ga-exendin uptake and C-peptide	• Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements.	12 months into treatment
Secondary	relative 68Ga-exendin uptake	• Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually	12 months into treatment