Investigating the effects of Verapamil on beta cell mass in Type 1 Diabetes using PET imaging
A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
This study is testing if the medication Verapamil can help increase the insulin-producing cells in the pancreas of people who have just been diagnosed with Type 1 Diabetes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Locations | 2 sites (Vienna and 1 other locations) |
| Trial ID | NCT04615910 on ClinicalTrials.gov |
What this trial studies
This trial aims to assess the pancreatic uptake of a radiotracer, 68Ga-NODAGA-exendin, using PET/CT imaging to evaluate changes in beta cell mass in patients with newly diagnosed Type 1 Diabetes after treatment with Verapamil. The study is part of the larger VER-A-T1D initiative, which explores the protective effects of Verapamil on beta cell function and apoptosis. Participants will undergo imaging at baseline and after 12 months to determine if Verapamil treatment leads to increased beta cell mass. The study involves collaboration among several prominent medical institutions across Europe.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 who have been diagnosed with Type 1 Diabetes within the last 6 weeks and have specific diabetes-related autoantibodies.
Not a fit: Patients with renal disease, those who are pregnant or planning to become pregnant, or those currently using certain diabetes medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new treatment strategies that preserve beta cell function in Type 1 Diabetes patients.
How similar studies have performed: While the approach of using PET imaging to assess beta cell mass is innovative, similar studies have shown promise in evaluating beta cell function and mass in diabetes.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Vienna and 1 other locations
- University of Vienna — Vienna, Austria (Recruiting)
- Assistance Publique hopitaux de Paris — Paris, France (Recruiting)
Study contacts
- Study coordinator: Marti Boss, PhD
- Email: marti.boss@radboudumc.nl
- Phone: +31614542555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.