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

Tracking Information

First Received Date ^ICMJE

January 4, 2010

Last Updated Date

November 2, 2012

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT01042301 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Identification and characterization of new profiles of humoral and cellular markers (including T cell reactivity and miRNA) related to type 1 diabetes (2010-2014).

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes

Official Title ^ICMJE

Profiling of Original Cellular and Humoral Biomarkers of 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).

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Type 1 Diabetes

Intervention ^ICMJE

Other: Blood samplings

Study Arm (s)

Experimental: Long-term type 1 diabetic patients
Long-term type 1 diabetic patients

Intervention: Other: Blood samplings
Active Comparator: control patients
control patients

Intervention: Other: Blood samplings
Experimental: diabetic and transplanted patients
diabetic and transplanted patients

Intervention: Other: Blood samplings
Experimental: subjects with high risk for diabetes
subjects with high risk for diabetes

Intervention: Other: Blood samplings
Experimental: patients with recent type 1 diabetes
patients with recent type 1 diabetes

Intervention: Other: Blood samplings
Experimental: patients with Latent Autoimmune Diabetes
patients with Latent Autoimmune Diabetes

Intervention: Other: Blood samplings

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

120

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

7 Years to 70 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Jean-Marie Bach

bach@vet-nantes.fr

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01042301

Other Study ID Numbers ^ICMJE

BRD07/5-A

Has Data Monitoring Committee

Yes

Responsible Party

Nantes University Hospital

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Lucy Chaillous

CHU de Nantes

Information Provided By

Nantes University Hospital

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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