Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients
|ClinicalTrials.gov Identifier: NCT01534169|
Recruitment Status : Completed
First Posted : February 16, 2012
Last Update Posted : November 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Graves' Disease||Drug: Dexamethasone||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Function of Regulatory T Cells Improved by Treatment With an Intrathyroid Injection of Dexamethasone in Graves' Patients|
|Study Start Date :||March 2012|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||November 2012|
U.S. FDA Resources
Experimental: Isotonic Na chloride
The treatment strategy is the same with intervention, only the drug (dexamethasone) will be changed to isotonic Na chloride.
The course of treatment will be last for 3 months. The intrathyroid injection of dexamethasone will be performed using a 25-gauge (0.25-mm) needle under ultrasound guidance. The injection will be performed in both lobes of the thyroid. The dosage of dexamethasone is 5mg (1.0 ml) in each lobe, twice a week during the first month of the treatment. The treatment strategy will be changed to once a week in the second month and twice a month in the third month; the dosage of dexamethasone is the same as in the first month.
Other Name: Hexadecadrol
- Function of Regulatory T Cells [ Time Frame: From baseline to 90 days ]Function of Treg cells will be analyzed by the proliferation rate of CD4+CD25- T cells, according to the following formula: cell proliferation rate (%) = proliferation rate of CD4+CD25- T cells co-cultured with CD4+CD25+T cells/proliferation rate of CD4+CD25- T cells alone×100%.
- The proportion of Th1 and Th2 cells [ Time Frame: From baseline to 90 days ]Th1 and Th2 cells will be identified by flow cytometry analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534169
|Nanjing First Hospital Affiliated to Nanjing Medical University|
|Nanjing, Jiangsu, China, 210006|
|Study Chair:||Xiao-Ming Mao, MD.||Nanjing First Hospital Affiliated to Nanjing Medical University|