Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes (Lymphoscreen)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood samplings
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes
Eligibility 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
Sites / Locations
- CHU de Nantes
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Long-term type 1 diabetic patients
control patients
diabetic and transplanted patients
subjects with high risk for diabetes
patients with recent type 1 diabetes
patients with Latent Autoimmune Diabetes
Arm Description
Long-term type 1 diabetic patients
control patients
diabetic and transplanted patients
subjects with high risk for diabetes
patients with recent type 1 diabetes
patients with Latent Autoimmune Diabetes
Outcomes
Primary Outcome Measures
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
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).
Full Information
NCT ID
NCT01042301
First Posted
January 4, 2010
Last Updated
September 7, 2015
Sponsor
Nantes University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01042301
Brief Title
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Acronym
Lymphoscreen
Official Title
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Long-term type 1 diabetic patients
Arm Type
Experimental
Arm Description
Long-term type 1 diabetic patients
Arm Title
control patients
Arm Type
Active Comparator
Arm Description
control patients
Arm Title
diabetic and transplanted patients
Arm Type
Experimental
Arm Description
diabetic and transplanted patients
Arm Title
subjects with high risk for diabetes
Arm Type
Experimental
Arm Description
subjects with high risk for diabetes
Arm Title
patients with recent type 1 diabetes
Arm Type
Experimental
Arm Description
patients with recent type 1 diabetes
Arm Title
patients with Latent Autoimmune Diabetes
Arm Type
Experimental
Arm Description
patients with Latent Autoimmune Diabetes
Intervention Type
Other
Intervention Name(s)
Blood samplings
Primary Outcome Measure Information:
Title
Identification and characterization of new CD8+ T lymphocytes related to type 1 diabetes and its evolution (2009-2012)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Chaillous
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
12. IPD Sharing Statement
Learn more about this trial
Profiling of Original Cellular and Humoral Biomarkers of Type 1 Diabetes
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