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The Role of Regulatory T Cell in Patients With Type 1 Diabetes Mellitus

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00173641
First received: September 12, 2005
Last updated: November 23, 2005
Last verified: September 2005
  Purpose
Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find the pathogenesis of this autoimmune disease.

Condition Intervention
Type 1 Diabetes Mellitus
Procedure: blood drawing

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Retrospective/Prospective

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Estimated Enrollment: 150
Study Start Date: September 2005
Estimated Study Completion Date: August 2006
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 CD4+CD25+ 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 CD4+CD25+ 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.

  Eligibility

Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • pediatric type 1 DM

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00173641

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yi-Ching Tung, MD National Taiwan University Hospital
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00173641     History of Changes
Other Study ID Numbers: 9461700823 
Study First Received: September 12, 2005
Last Updated: November 23, 2005
Health Authority: Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on December 05, 2016