A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
NCT ID: NCT04615910
Last Updated: 2023-12-08
Study Results
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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RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2021-07-01
2025-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Verapamil
Patients treated with Verapamil within the Ver-A-T1D trial
68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT
Placebo
Patients treated with placebo within the Ver-A-T1D trial
68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT
Interventions
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68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT
Eligibility Criteria
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Inclusion Criteria
* • 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
* Pregnancy or the wish to become pregnant within 2 months after the second PET/CT scan.
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Medical University of Vienna
OTHER
Bart's London
UNKNOWN
KU Leuven
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Locations
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University of Vienna
Vienna, , Austria
Assistance Publique hopitaux de Paris
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Oana Kulterer, MD
Role: primary
Jean-Noel Talbot, PhD
Role: primary
Other Identifiers
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20201013
Identifier Type: -
Identifier Source: org_study_id