Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00212329
Status:
COMPLETED
Last Update Posted:
2016-05-13
First Post:
2005-09-13
Brief Title:
T Cell Validation Study Using Blood Samples From Subjects With Recent Onset Type 1 Diabetes Mellitus
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Study Overview
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
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None