Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00173641
Status:
UNKNOWN
Last Update Posted:
2005-11-24
First Post:
2005-09-12
Brief Title:
The Role of Regulatory T Cell in Patients With Type 1 Diabetes Mellitus
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2005-09
Last Known Status:
RECRUITING
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:
Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus and find the pathogenesis of this autoimmune disease
Detailed Description:
Type 1 diabetes mellitus T1D is an autoimmune disease characterized with T cell mediated destruction of pancreatic βcell Dysregulated B and T cells were reported in the animal model The loss of maintenance of immune homeostasis is thought to be major mechanism and result in persistence of autoreactive T cell in the periphery Therapies which modulate the immune dysfunction may be helpful for the patients of T1D
Immune homeostasis means a balance between the responses that control infection and tumor growth and reciprocal responses that prevent inflammation and autoimmune disease CD4 CD25 regulatory T cells Tregs are critical to maintain such functions Their actions can be through cell-to-cell contact or bystander effect The specific markers of Tregs include CD25 molecule IL-2 receptorαchain Foxp3 forkhead-winged helix transcription factor The Foxp3 is a transcription factor that controls some genes encoding Tregs associated molecules such as CD25 CTLA-4 and GITR
The previous studies of modulation of Tregs in T1D show positive results in animal model But the relative sizes of CD4CD25 population in human are still controversial Our hypothesis is that the imbalance of Tregs and autoreactive T cells is the pathogenesis of T1D Therefore we used flow cytometry to determine the number of CD4CD25 Tregs population and quantitative real-time PCR to assay the expression of Foxp3 CLTA-4 GITR in patients with different stages and normal control Besides autoantibodies to GAD65 is associated with T1D in 60-80 patients It is a marker of autoimmune diabetes We anticipated that the realization of Tregs functions in patients of T1D will help our further guide of immunotherapy of patients with T1D and other autoimmune disease
Immune homeostasis means a balance between the responses that control infection and tumor growth and reciprocal responses that prevent inflammation and autoimmune disease CD4 CD25 regulatory T cells Tregs are critical to maintain such functions Their actions can be through cell-to-cell contact or bystander effect The specific markers of Tregs include CD25 molecule IL-2 receptorαchain Foxp3 forkhead-winged helix transcription factor The Foxp3 is a transcription factor that controls some genes encoding Tregs associated molecules such as CD25 CTLA-4 and GITR
The previous studies of modulation of Tregs in T1D show positive results in animal model But the relative sizes of CD4CD25 population in human are still controversial Our hypothesis is that the imbalance of Tregs and autoreactive T cells is the pathogenesis of T1D Therefore we used flow cytometry to determine the number of CD4CD25 Tregs population and quantitative real-time PCR to assay the expression of Foxp3 CLTA-4 GITR in patients with different stages and normal control Besides autoantibodies to GAD65 is associated with T1D in 60-80 patients It is a marker of autoimmune diabetes We anticipated that the realization of Tregs functions in patients of T1D will help our further guide of immunotherapy of patients with T1D and other autoimmune disease
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