NCT01846312已完成不适用
The Longitudinal Diabetes Biomarker Study: An Observational Study to Assess Longitudinal Variation of Immune Biomarkers in Subjects at Risk for Development of Type 1 Diabetes
适应症
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
- Fluctuation in islet autoantibodies titers
研究概览
简要总结
This study is conducted in the United States of America (USA). The aim of the study is to assess longitudinal variation of immune biomarkers in subjects at risk for development of type 1 diabetes (T1D).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with general good health as judged by the investigator
- •Participant tested positive at above or equal to 99th percentile for one or more of three islet antibodies (GAD (glutamic acid decarboxylase), IA2 (islet antigen-2), IAA (insulin autoantibody))
排除标准
- •Any chronic disorder (diabetes at enrolment) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol
- •Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant
结局指标
主要结局
Fluctuation in islet autoantibodies titers
时间窗: One-two years dependent on sampling frequency
次要结局
- Fluctuation in islet autoantibody isotypes(One-two years dependent on sampling frequency)
- Fluctuation in T-cell specificity profiling (mainly for CD8 (cluster of differentiation 8) T-cells)(One-two years dependent on sampling frequency)
研究者
研究点 (1)
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