Immune Response to Extracellular Vesicles Released by Human Islets of Langerhans
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine the levels of circulating EVs
研究概览
简要总结
Beta-cells release extracellular vesicles (EV) and exosomes under normal and pathophysiologic conditions. These EV contain beta-cell specific autoantigens which may trigger the immune response at the initiation of type 1 diabetes. In this study, beta-cell derived EV will be detected and characterized in human blood samples.
详细描述
Adult subjects will be recruited with: new onset type 1 diabetes mellitus (T1DM), type 2 diabetes mellitus (T2DM) as well as islet transplant candidates. Blood samples will be collected at defined intervals to determine beta-cell specific EV and determine the utility of this biomarker as a measure of beta-cell stress or injury.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-70 Diagnosis of type 1 diabetes or type 2 diabetes or islet transplant recipient
排除标准
- •Unknown diagnosis of diabetes Active infection Immunocompromised Organ transplant recipients not including candidates for islet transplant HIV+ Hepatitis C+ Hepatitis B surface antigen+ Known concurrent malignancy Known pregnancy
结局指标
主要结局
Determine the levels of circulating EVs
时间窗: 2 years
Based on well-known EV markers, subject plasma samples will be characterized to determine whether these EVs are detectable using small particle flow cytometry.
Determine whether these EVs contain islet-specific antigens
时间窗: 2 years
EVs will be further characterized using small particle flow cytometry for known islet-specific antigens such as GAD65 and ZnT8
次要结局
- Mutivariate analysis will be performed with patient parameters and EV parameters(3 years)
研究者
Dr. Steven Paraskevas
Associate Professor of Surgery
McGill University Health Centre/Research Institute of the McGill University Health Centre