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

This study is currently recruiting participants.
Verified November 2012 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01042301
First received: January 4, 2010
Last updated: November 2, 2012
Last verified: November 2012
History of Changes
  Purpose

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).


Condition Intervention
Type 1 Diabetes
 Other: Blood samplings

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014). [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: September 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Long-term type 1 diabetic patients
Long-term type 1 diabetic patients
 Other: Blood samplings
Active Comparator: control patients
control patients
 Other: Blood samplings
Experimental: diabetic and transplanted patients
diabetic and transplanted patients
 Other: Blood samplings
Experimental: subjects with high risk for diabetes
subjects with high risk for diabetes
 Other: Blood samplings
Experimental: patients with recent type 1 diabetes
patients with recent type 1 diabetes
 Other: Blood samplings
Experimental: patients with Latent Autoimmune Diabetes
patients with Latent Autoimmune Diabetes
 Other: Blood samplings

  Eligibility

Ages Eligible for Study:   7 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01042301

Contacts
Contact: Jean-Marie Bach bach@vet-nantes.fr

Locations
France
CHU de Nantes Recruiting
Nantes, France, 44093
Contact: Lucy Chaillous         Lucy.chaillous@chu-nantes.fr    
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Lucy Chaillous CHU de Nantes
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01042301     History of Changes
Other Study ID Numbers: BRD07/5-A
Study First Received: January 4, 2010
Last Updated: November 2, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013