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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01042301
First received: January 4, 2010
Last updated: September 18, 2013
Last verified: September 2013
  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:


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 ]

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042301

Locations
France
CHU de Nantes
Nantes, France, 44093
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: September 18, 2013
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 August 26, 2014