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

Trial ID or NCT#

NCT00212329

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 8 Years to 35 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. 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:
  1. Individuals must not: - Have any major illness - Be taking any steroid medications - If female, should not be pregnant or breastfeeding.
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Investigator(s)

Darrell Wilson

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Contact

Alison Rigby
8772325182

View on ClinicalTrials.gov