A GLP-1 Receptor PET Imaging Substudy Within the VER-A-T1D Trial Investigating the Effects on Beta Cell Mass
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Pancreatic 68Ga-exendin uptake
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• 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
排除标准
- •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.
结局指标
主要结局
Pancreatic 68Ga-exendin uptake
时间窗: 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
次要结局
- relative 68Ga-exendin uptake(12 months into treatment)
- Correlation of 68Ga-exendin uptake and C-peptide(12 months into treatment)