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

December 7, 2023 updated by: Radboud University Medical Center
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Vienna, Austria
        • Recruiting
        • University of Vienna
        • Contact:
          • Oana Kulterer, MD
  • France
      • Paris, France
        • Recruiting
        • Assistance Publique Hopitaux De Paris
        • Contact:
          • Jean-Noel Talbot, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Verapamil
Patients treated with Verapamil within the Ver-A-T1D trial
Radiation: 68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT
Placebo Comparator: Placebo
Patients treated with placebo within the Ver-A-T1D trial
Radiation: 68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pancreatic 68Ga-exendin uptake
Time Frame: Change from time of inclusion to 12 months into treatment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of 68Ga-exendin uptake and C-peptide
Time Frame: 12 months into treatment
• Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements.
12 months into treatment
relative 68Ga-exendin uptake
Time Frame: 12 months into treatment
• Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually
12 months into treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

Assistance Publique - Hôpitaux de Paris
Medical University of Vienna
KU Leuven
Bart's London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

July 1, 2025

Study Registration Dates

First Submitted

October 22, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20201013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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