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

Status:	Completed
Conditions:	Diabetes, Diabetes
Therapuetic Areas:	Endocrinology
Healthy:	No
Age Range:	8 - 35
Updated:	5/14/2016
Start Date:	September 2005
End Date:	September 2007

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

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.

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

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.

We found this trial at

sites

University of California at San Francisco

San Francisco, California 94143

from

San Francisco, CA