Sequencing T-cell Receptor Repertoire of Auto-Antigen Specific T-cells in Type I Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes
研究概览
简要总结
The purpose of this study is to investigate CD8 + T-cell receptor (TCR) repertoire differences between patients with type 1 diabetes mellitus and type 2 diabetes or healthy controls.
详细描述
Using a systems biology approach by combining high-throughput sequencing, cytometry, gene expression, transcriptome profiling, HLA typing, single cell analysis, and TCR affinity assays, the investigators will define a set of immune metrics for the prediction or early diagnosis of disease that is superior to the current examination of auto-antibodies, which is a fairly late stage in the disease development. This can also be used to guide therapy in advanced disease.
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients must have a current or previous diagnosis of Type I Diabetes (Autoimmune-related T1DA as confirmed by a positive test for glutamic acid decarboxylase (GAD) auto-antibodies. When available, idiopathic T1DB patients with a lack of autoantibodies to GAD will be recruited)
- •Patients must be ≥ 18 years old and ≤55 years old
- •Inclusion criteria: patients T2D as controls
- •Patients must have a current or previous diagnosis of T2D
- •Patients must be ≥ 18 years old and ≤55 years old
排除标准
- •<18 years old; > 55 years old
结局指标
主要结局
Sensitivity and specificity of T cell repertoire analysis to classify Type I Diabetes
时间窗: 3 month intervals for 2 years. Time to assess effectiveness is 1 year.
次要结局
未报告次要终点