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| Name | Class |
|---|---|
| Assistance Publique - Hôpitaux de Paris | OTHER |
| Medical University of Vienna | OTHER |
| Bart's London | UNKNOWN |
| KU Leuven |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Verapamil | Experimental | Patients treated with Verapamil within the Ver-A-T1D trial |
|
| Placebo | Placebo Comparator | Patients treated with placebo within the Ver-A-T1D trial |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NODAGA-exendin-4 PET/CT | Radiation | 68Ga-NODAGA-exendin-4 PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| relative 68Ga-exendin uptake |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marti Boss, PhD | Contact | +31614542555 | marti.boss@radboudumc.nl | |
| Martin Gotthardt, MD | Contact | +31242613813 | martin.gotthardt@radboudumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Vienna | Recruiting | Vienna | Austria |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| OTHER |
Type 1 Diabetes Mellitus
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• Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually
| 12 months into treatment |
| Assistance Publique hopitaux de Paris | Recruiting | Paris | France |
|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |