T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
- Conditions
- Type 1 Diabetes Mellitus
- Registration Number
- NCT00212329
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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.
Individuals must not:
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Childrens Hospital of Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Barbara Davis Center for Childhood Diabetes
🇺🇸Denver, Colorado, United States
University of Miami School of Medicine
🇺🇸Miami, Florida, United States
Riley Hospital for Children
🇺🇸Indianapolis, Indiana, United States
Naomi Berrie Diabetes Center, Columbia University
🇺🇸New York, New York, United States
Benaroya Research Institute at Virginia Mason
🇺🇸Seattle, Washington, United States
Children's Hospital of Pittsburgh of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
University of Florida
🇺🇸Gainesville, Florida, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Bristol
🇬🇧Bristol, United Kingdom
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States