NCT01900834已完成不适用
An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
研究概览
简要总结
This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.
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
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects diagnosed within the last 3 years and with good general health based on medical history
- •Age above or equal to 14 years and below or equal to 40 years
- •Body weight above 45 kg
- •Male or female subjects diagnosed within the last 15 years with good general health based on medical history
- •HbA1c between 6.5% and 10%
- •Body mass index (BMI) below 45 kg/m^2
- •Age above or equal to 18 and below 65 years
- •On insulin treatment
- •Male or female subjects with good general heath based on medical history
- •Age above or equal to 18 years and below or equal to 40 years
排除标准
- •Any chronic disorder (besides T1D or T2D) 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
Variation in CD8 (cluster of differentiation) +T-cell specificity profiling
时间窗: Over a one year period
次要结局
- Variation in CD4 +T-cell specificity profiling(Over a one year period)
- Change in stimulated C-peptide(Baseline, one year)
- Variation in HbA1c (glycosylated haemoglobin)(Over a one year period)
- Fluctuation in islet autoantibodies titers(Over a one year period)
研究者
研究点 (1)
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