Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Blood samplings

• Registration Number: NCT01042301
• Lead Sponsor: Nantes University Hospital

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-04
• Study First Posted: 2010-01-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-07
• Last Update Posted: 2015-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
patients with recent type 1 diabetes	Blood samplings	patients with recent type 1 diabetes
Long-term type 1 diabetic patients	Blood samplings	Long-term type 1 diabetic patients
control patients	Blood samplings	control patients
subjects with high risk for diabetes	Blood samplings	subjects with high risk for diabetes
diabetic and transplanted patients	Blood samplings	diabetic and transplanted patients
patients with Latent Autoimmune Diabetes	Blood samplings	patients with Latent Autoimmune Diabetes

Primary Outcome Measures

Name	Time	Method
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)	3 years

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU de Nantes; 🇫🇷 Nantes, France