Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001985
Status:
COMPLETED
Last Update Posted:
2008-03-05
First Post:
2000-01-26
Brief Title:
Genetic Influence on Susceptibility to Type 1 Diabetes Mellitus
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Multi-Center Study to Determine Whether CD 152 Gene Polymorphisms Associated With Susceptibility to Type-1-Diabetes Mellitus T1DM Correspond With Abnormalities in T Cell Function
Status:
COMPLETED
Status Verified Date:
2003-02
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 mellitus is an autoimmune disease in which the bodys immune cells attack the insulin-producing cells of the pancreas Several environmental and genetic factors may predispose individuals to developing this disease including changes in a gene called CD152 This study will examine how this gene may influence the development of insulin-dependent diabetes
Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes of Health and at the University of Florida and healthy normal volunteers may participate in this study Participants will have up to three blood samples drawn over a period of less than 1 year The first sample about 20 milliliters or 4 teaspoons will be examined for changes in the structure of the CD152 gene If the CD152 structure is different from that normally seen in the general population a second sample about 90 ml or 6 tablespoons of blood will be drawn This sample will be used to study the function of specialized immune system cells T cells including their growth and survival chemicals they produce when stimulated and other factors If these cells function differently from what is generally seen in the population a third sample 90 ml will be drawn for more detailed studies
This investigation may help explain what makes certain individuals susceptible to Type 1 diabetes mellitus and may contribute to the development of improved treatments for the disease
Patients with Type 1 diabetes mellitus enrolled in clinical trials at the National Institutes of Health and at the University of Florida and healthy normal volunteers may participate in this study Participants will have up to three blood samples drawn over a period of less than 1 year The first sample about 20 milliliters or 4 teaspoons will be examined for changes in the structure of the CD152 gene If the CD152 structure is different from that normally seen in the general population a second sample about 90 ml or 6 tablespoons of blood will be drawn This sample will be used to study the function of specialized immune system cells T cells including their growth and survival chemicals they produce when stimulated and other factors If these cells function differently from what is generally seen in the population a third sample 90 ml will be drawn for more detailed studies
This investigation may help explain what makes certain individuals susceptible to Type 1 diabetes mellitus and may contribute to the development of improved treatments for the disease
Detailed Description:
Genetic variations in CD152 have been reported to confer susceptibility to the development of type-1-diabetes mellitus T1DM In this protocol we will draw blood samples from patients and normal control volunteers in order to analyze for the presence of CD152 genetic variations and to determine whether those variations are associated with measurable abnormalities in T cell function Subjects with T1DM and homozygous CD152 gene polymorphisms patients with T1DM but without CD152 polymorphisms and control subjects with or without CD152 polymorphisms will be studied to determine whether the CD152 polymorphisms have measurable effects on T cell function and signaling We will assess T cell function by measuring proliferation viability apoptosis cytokine production and T cell signal transduction The identification and characterization of genes that are linked to T1DM may provide an explanation into the mechanisms by which individuals are predisposed to T1DM
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-DK-0063 | None | None | None |