Status:
COMPLETED
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
8-35 years
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 c...
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 t...
Eligibility Criteria
Inclusion
- 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
- Individuals must not:
- Have any major illness
- Be taking any steroid medications
- If female, should not be pregnant or breastfeeding.
Key Trial Info
Start Date :
September 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00212329
Start Date
September 1 2005
End Date
September 1 2007
Last Update
May 13 2016
Active Locations (14)
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1
Childrens Hospital of Los Angeles
Los Angeles, California, United States, 90027
2
University of California, San Francisco
San Francisco, California, United States, 94143-0136
3
Stanford University Medical Center
Stanford, California, United States, 94305-5208
4
Barbara Davis Center for Childhood Diabetes
Denver, Colorado, United States, 80010