Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
研究概览
简要总结
The "Lymphoscreen" study aims to characterize precisely (phenotypes/cytokines/functions) CD8+ T cell responses in type 1 Diabetes to identify biomarkers of the disease. Such markers are needed for refine type 1 Diabetes diagnosis/prognostic, and to design new therapeutic approaches targeting autoreactive CD8+ T cells. An original approach using DNA immunization of humanized mice allowed us to identify relevant CD8 epitopes derived from GAD65 and IA-2 beta cell autoantigens. The aims are: (i) identifying exhaustively epitopes recognized by autoreactive CD8+ T lymphocytes in type 1 Diabetes and following islet or pancreas graft in humans; (ii) identifying pathogenic CD8+ T cell patterns or profiles related to type 1 Diabetes pathogenesis and evolution; (iii) correlating CD8+ autoreactive T cell responses and autoantibody responses to new cellular (such as CD4+ T cells or peripheral cell miRNA) or humoral markers of the disease (such as serum miRNA).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least, 50 patients with "recent" type 1 diabetes,
- •30 patients with long-term type 1 diabetes,
- •10 patients with Latent Autoimmune Diabetes,
- •10 subjects with a risk for diabetes,
- •20 type 1 diabetic patients with pancreatic graft or Langerhans islet graft.
- •50 healthy subjects paired to HLA class I and to the age
- •Those subjects have to respect the following criteria :
- •Age from 7 to 70 -Caucasian
- •Affiliated to a national insurance scheme
- •Written informed consent obtained For children, written informed consent is required from the two parents.
- •Non-inclusion criteria :
- •Age strictly inferior to 7 or strictly superior to 70 years old
- •Pregnancy
- •Secondary diabetes
- •No written informed consent
排除标准
- 未提供
研究组 & 干预措施
Long-term type 1 diabetic patients
Long-term type 1 diabetic patients
干预措施: Blood samplings (Other)
control patients
control patients
干预措施: Blood samplings (Other)
diabetic and transplanted patients
diabetic and transplanted patients
干预措施: Blood samplings (Other)
subjects with high risk for diabetes
subjects with high risk for diabetes
干预措施: Blood samplings (Other)
patients with recent type 1 diabetes
patients with recent type 1 diabetes
干预措施: Blood samplings (Other)
patients with Latent Autoimmune Diabetes
patients with Latent Autoimmune Diabetes
干预措施: Blood samplings (Other)
结局指标
主要结局
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
时间窗: 3 years
次要结局
- Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).(3 years)