2024-518554-17-00招募中2 期
A GLP-1 receptor PET imaging add-on study within the VERA-T1D trial investigating the effects on beta cell mass (Image-VER-A-T1D)
Radboud universitair medisch centrum Stichting4 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2025年1月30日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.
研究概览
简要总结
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 and inter-individual differences between the treatment group and the placebo group.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Are included in the VER-A-T1D trial, but have not started treatment/placebo.
- •have given written informed consent.
- •Age ≥18 years at consent
排除标准
- •Treatment with synthetic exendin (Exentide, Byetta®) or dipeptidyl-peptidase IV inhibitors (to exclude interferences with imaging), specifically mentioned although in principle part of exclusion criteria VER-A-T1D.
- •Renal disease defined as MDRD < 40 ml/min/1.73m²
- •Pregnancy or the wish to become pregnant within 2 months after second PET/CT scan.
结局指标
主要结局
The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.
The total pancreatic uptake of 68Ga-NODAGA-exendin for determination of beta cell mass at the point of inclusion and after 12 months.
次要结局
- Changes in 68Ga-NODAGA-exendin pancreas uptake in realtion to changes in C-peptide measurements.
- Changes in 68Ga-NODAGA-exendin pancreas uptake in relation to changes in proinsulin/preproinsulin measurements.
- Differences in 68Ga-NODAGA-exendin uptake between individuals and between the two timepoints of imaging intra-individually
研究者
Sevilay Tokgöz
Scientific
Radboud universitair medisch centrum Stichting
研究点 (4)
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