Detection of Human Beta Cell Death in T1DM by Methylation Specific PCR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Develop sensitive, specific, and quantitative methylation- specific PCR assays for the detection of human beta cell-specific DNA methylation patterns cells and the onset of metabolic dysregulation.
研究概览
简要总结
To investigate the use of methylation-specific PCR (MSP) assays to detect human beta cell-specific gene methylation patterns in serial blood samples drawn from newly diagnosed Type 1 diabetics.
详细描述
The study will follow 25 newly diagnosed type 1 diabetic patients from the onset of symptoms to one year post-diagnosis. A total of 11 fasting blood draws will be taken, the first near the time of diabetes diagnosis, then 2 weeks later, monthly for the next 6 months, and every other month until 12 months. Each blood sample will be evaluated by the MSP assay, as well as for measurement of fasting plasma glucose, HbA1c, c-peptide, and autoantibodies. The study will also need 25 healthy volunteers to help us match some DNA markers needed for this data. Healthy volunteers will be se=matched healthy individuals who have one blood sample drawn.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers:
- •Age > 18 years of age,
- •Otherwise healthy individuals with no cancer and not pregnant.
- •Newly diagnosed type I diabetes,
- •Age > 18 years of age,
- •Otherwise healthy individuals with no severe complications, no cancer, not pregnant,
- •Willing and able to comply with the scheduled visits to the clinic for blood sampling,
- •Remain under the continuing care of an Endocrinologist.
排除标准
- 未提供
结局指标
主要结局
Develop sensitive, specific, and quantitative methylation- specific PCR assays for the detection of human beta cell-specific DNA methylation patterns cells and the onset of metabolic dysregulation.
时间窗: 1 year post diagnosis
Use the assays to detect beta cell destruction throughout the early time-course of type 1 diabetes mellitus
时间窗: 1 year post diagnosis
次要结局
未报告次要终点