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

Type 1 Diabetes Mellitus Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

• NCT number: NCT00212329
• Study type: Observational
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Status: Completed
• Phase: N/A
• Start date: September 2005
• Completion date: September 2007