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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
ClinicalTrials.gov Identifier:
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Taiwan University Hospital
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.


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Ages Eligible for Study:   1 Month to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • pediatric type 1 DM

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173641

Contact: Yi-Ching Tung, MD 886-2-23123456 ext 5130 dtped004@yahoo.com.tw

National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Yi-Ching Tung, MD    886-2-23123456 ext 5130    dtped004@yahoo.com.tw   
Sub-Investigator: Yi-Ching Tung, MD         
Sponsors and Collaborators
National Taiwan University Hospital
Principal Investigator: Yi-Ching Tung, MD National Taiwan University Hospital
  More Information

ClinicalTrials.gov Identifier: NCT00173641     History of Changes
Other Study ID Numbers: 9461700823
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

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