Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— Lymphoscreen  

Official title:

Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01042301
• Other study ID #: BRD07/5-A
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: September 7, 2015
• Start date: September 2007
• Est. completion date: October 2014

Study information

• Verified date: September 2015
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 7 Years to 70 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Blood samplings

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)		3 years	No
Secondary	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	No