Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes (Lymphoscreen)

Nantes University Hospital (NUH)

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Blood samplings

Study type: Interventional

Funder types: Other

Identifiers

NCT01042301

BRD07/5-A

Details and patient eligibility

About

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).

Enrollment: 120 patients

Sex: All

Ages: 7 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 6 patient groups

Long-term type 1 diabetic patients

Experimental group

Description:

Long-term type 1 diabetic patients

Treatment:

Other: Blood samplings

control patients

Active Comparator group

Description:

control patients

Treatment:

Other: Blood samplings

diabetic and transplanted patients

Experimental group

Description:

diabetic and transplanted patients

Treatment:

Other: Blood samplings

subjects with high risk for diabetes

Experimental group

Description:

subjects with high risk for diabetes

Treatment:

Other: Blood samplings

patients with recent type 1 diabetes

Experimental group

Description:

patients with recent type 1 diabetes

Treatment:

Other: Blood samplings

patients with Latent Autoimmune Diabetes

Experimental group

Description:

patients with Latent Autoimmune Diabetes

Treatment:

Other: Blood samplings