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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00212329

Enrollment

100

Registered

2005-09-21

Start date

2005-09-30

Completion date

2007-09-30

Last updated

2016-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes, Juvenile Onset Diabetes, Insulin Dependent Diabetes, T1D

Brief 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

Interventions

PROCEDURET Cell Proliferation and Autoreactivity Assays

PROCEDURECellular Immunoblot Assays

PROCEDURETetramer Studies

PROCEDURECytokine ELISPOT

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 35 Years

Healthy volunteers

Yes

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.

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026