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

Not Recruiting

Trial ID: NCT00212329


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

Stanford Investigator(s)


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.


procedure: T Cell Proliferation and Autoreactivity Assays

procedure: Cellular Immunoblot Assays

procedure: Tetramer Studies

procedure: Cytokine ELISPOT

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Alison Rigby