NCT00212329

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years – 35 Years
• Healthy volunteers: Accepted

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

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
PROCEDURE	T Cell Proliferation and Autoreactivity Assays
PROCEDURE	Cellular Immunoblot Assays
PROCEDURE	Tetramer Studies
PROCEDURE	Cytokine ELISPOT

Timeline

• Start date: 2005-09-01
• Completion: 2007-09-01
• First posted: 2005-09-21
• Last updated: 2016-05-13

Locations

14 sites across 2 countries: United States, United Kingdom