Diabetes Mellitus
Conditions
Keywords
Verapamil, Type 1 Diabetes Mellitus, exendin, Beta cell mass, PET imaging
Brief 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.
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.
Interventions
RADIATION68Ga-NODAGA-exendin-4 PET/CT
68Ga-NODAGA-exendin-4 PET/CT
Sponsors
Assistance Publique - Hôpitaux de Paris
Medical University of Vienna
Bart's London
KU Leuven
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Investigator)
Intervention model description
Type 1 Diabetes Mellitus
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pancreatic 68Ga-exendin uptake | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of 68Ga-exendin uptake and C-peptide | 12 months into treatment | • Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements. |
| relative 68Ga-exendin uptake | 12 months into treatment | • Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually |
Countries
Austria, France
Contacts
Primary ContactMarti Boss, PhD
Backup ContactMartin Gotthardt, MD
Outcome results
None listed