T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Type 1 diabetes is a condition that is caused in part by an abnormality of the immune system which occurs when T cells, which are part of the immune system, damage the insulin secreting cells (islet cells) in the pancreas. Although it is known that T cells are important mediators of the disease, progress in the development of reliable T cell assays has been modest. The purpose of this study is to learn which T cell assays are most reliable and reproducible so that the investigators can improve their understanding about how type 1 diabetes occurs.

Detailed Description
-----------------
The T Cell Validation Study is designed to determine the ability of T cell assays to identify differences in responses from participants with type 1 diabetes compared to normal control subjects, and to compare four different laboratory tests which examine T cells to determine whether the measurements are quantitatively reproducible. Antibody assays that confirm the presence of type 1 diabetes will be evaluated including: Diabetes Biochemical Autoantibody Assay (anti-GAD65, anti-ICA512, anti-insulin) and Islet Cell Autoantibody testing; genetic testing (deoxyribonucleic acid [DNA] and human leukocyte antigen [HLA]) will also be done to learn more about the T cell assays. The following T Cell Assays will be conducted in individuals with type 1 diabetes, as well as those without type 1 diabetes: Cellular Immunoblot Testing T Cell Proliferation Assay Tetramer Assay Cytokine ELISpot Assay

Official Title
-----------------
A Comparative Study Between the Cytokine Elispot, Tetramer, Immunoblot, and T Cell Proliferation Assays Using Fresh Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Procedure: T Cell Proliferation and Autoreactivity Assays
* Procedure: Cellular Immunoblot Assays
* Procedure: Tetramer Studies
* Procedure: Cytokine ELISPOT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be eligible, individuals with type 1 diabetes must be: Diagnosed with type 1 diabetes within one year of first study visit 8-35 years of age at time of first visit Weigh > 40 kg (88 lbs) at time of first visit Individuals who will serve as control subjects who do not have type 1 diabetes cannot have a first degree or second degree relative with type 1 diabetes. Exclusion Criteria: Individuals must not: Have any major illness Be taking any steroid medications If female, should not be pregnant or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: T Cell Proliferation and Autoreactivity Assays|nan|
|Procedure: Cellular Immunoblot Assays|nan|
|Procedure: Tetramer Studies|nan|
|Procedure: Cytokine ELISPOT|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 Diabetes, Juvenile Onset Diabetes, Insulin Dependent Diabetes, T1D