Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2014-10-31

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).

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

* 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.

* Age strictly inferior to 7 or strictly superior to 70 years old
* Pregnancy
* Secondary diabetes
* No written informed consent

Minimum Eligible Age

7 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes