Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Study Overview
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Brief Summary
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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).

Official Title
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Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Blood samplings


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term type 1 diabetic patients<br>Long-term type 1 diabetic patients | Other: Blood samplings<br> <br> |
| Active Comparator: control patients<br>control patients | Other: Blood samplings<br> <br> |
| Experimental: diabetic and transplanted patients<br>diabetic and transplanted patients | Other: Blood samplings<br> <br> |
| Experimental: subjects with high risk for diabetes<br>subjects with high risk for diabetes | Other: Blood samplings<br> <br> |
| Experimental: patients with recent type 1 diabetes<br>patients with recent type 1 diabetes | Other: Blood samplings<br> <br> |
| Experimental: patients with Latent Autoimmune Diabetes<br>patients with Latent Autoimmune Diabetes | Other: Blood samplings<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012) |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |