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Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01042301
Acronym
Lymphoscreen
Enrollment
120
Registered
2010-01-05
Start date
2007-09-30
Completion date
2014-10-31
Last updated
2015-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes

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).

Interventions

Sponsors

Nantes University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Secondary

MeasureTime 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026