The Role of Regulatory T Cell in Patients With Type 1 NCT00173641

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT00173641
Other study ID #	9461700823
Secondary ID
Status	Recruiting
Phase	N/A
First received	September 12, 2005
Last updated	November 23, 2005
Start date	September 2005
Est. completion date	August 2006

Study information
Verified date	September 2005
Source	National Taiwan University Hospital
Contact	Yi-Ching Tung, MD
Phone	886-2-23123456
Email	dtped004[@]yahoo.com.tw
Is FDA regulated	No
Health authority	Taiwan: Department of Health
Study type	Observational

Clinical Trial Summary

Evaluate the regulatory T cell function in patients with type 1 diabetes mellitus, and find the pathogenesis of this autoimmune disease.

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.

Recruitment information / eligibility
Status	Recruiting
Enrollment	150
Est. completion date	August 2006
Est. primary completion date
Accepts healthy volunteers	Accepts Healthy Volunteers
Gender	Both
Age group	1 Month to 20 Years
Eligibility	Inclusion Criteria: - pediatric type 1 DM Exclusion Criteria:

Study Design

Observational Model: Defined Population, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Intervention

Procedure:
• blood drawing

Locations
Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors *(1)*
Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan,

References & Publications (1)

Putnam AL, Vendrame F, Dotta F, Gottlieb PA. CD4+CD25high regulatory T cells in human autoimmune diabetes. J Autoimmun. 2005 Feb;24(1):55-62. Epub 2005 Jan 12. — View Citation

See also
Status	Clinical Trial	Phase
Completed	`NCT04476472` - Omnipod Horizon™ Automated Glucose Control System Preschool Cohort	N/A
Completed	`NCT03635437` - Evaluation of Safety and Diabetes Status Upon Oral Treatment With GABA in Patients With Longstanding Type-1 Diabetes	Phase 1/Phase 2
Completed	`NCT04909580` - Decision Coaching for Youth and Parents Considering Insulin Delivery Methods for Type 1 Diabetes	N/A
Active, not recruiting	`NCT00679042` - Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol	Phase 3
Completed	`NCT03293082` - Preschool CGM Use and Glucose Variability in Type 1 Diabetes	N/A
Completed	`NCT04016662` - Automated Insulin Delivery in Elderly With Type 1 Diabetes (AIDE T1D)	Phase 4
Completed	`NCT02527265` - Afrezza Safety and Pharmacokinetics Study in Pediatric Patients	Phase 2
Completed	`NCT03738865` - G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes	Phase 3
Completed	`NCT03240432` - Wireless Innovation for Seniors With Diabetes Mellitus	N/A
Completed	`NCT03168867` - Effectiveness Trial of an E-Health Intervention To Support Diabetes Care in Minority Youth (3Ms)	N/A
Completed	`NCT03674281` - The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System	N/A
Completed	`NCT03669770` - Ultrasound Classification and Grading of Lipohypertrophy and Its Impact on Glucose Variability in Type 1 Diabetes
Recruiting	`NCT03682640` - Azithromycin Insulin Diet Intervention Trial in Type 1 Diabetes	Phase 2
Recruiting	`NCT04096794` - Chinese Alliance for Type 1 Diabetes Multi-center Collaborative Research
Completed	`NCT02882737` - The Impact of Subcutaneous Glucagon Before, During and After Exercise a Study in Patients With Type 1 Diabetes Mellitus	N/A
Recruiting	`NCT02745808` - Injectable Collagen Scaffold™ Combined With HUC-MSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Withdrawn	`NCT02579148` - Collagen Scaffolds Loaded With HUCMSCs for the Improvement of Erectile Function in Men With Diabetes	Phase 1
Completed	`NCT02558491` - Feasibility of a Decision Support System to Reduce Glucose Variability in Subject With T1DM	N/A
Completed	`NCT02596204` - Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring	N/A
Withdrawn	`NCT02518022` - How to be Safe With Alcoholic Drinks in Diabetes	N/A

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

Clinical Trial Details — Status: Recruiting

Administrative data

Study information