Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients
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|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|
|Primary Completion Date :||March 2012|
|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.
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): 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|