Clinical Trial: Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Function of Regulatory T Cells Improved by Treatment With an Intrathyroid Injection of Dexamethasone in Graves' Patients

Brief Summary: Antithyroid drugs is the first choice treatment of Graves' disease in China and Europe. However,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients need further treatment. In our previous study, a new treatment strategy for GD has been introduced. After methimazole (18 months) combined with intrathyroid injection of dexamethasone (DEX) (3 months) treatment, the relapse rate of hyperthyroidism was markedly reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year follow-up period. The results have been published in the 'J Clin Endocrinol Metab, 2009,94:4984-4991'. However, the mechanism by which the DEX reduces the relapse rate of GD is not fully understood. In vitro study, we have proven that DEX could effectively improve the function of regulatory T (Treg) cells and set up a new balance of T helper 1(Th1)/Th2 in GD patients(this results have been in press in the Eur J Endocrinol). In order to elucidate mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with GD and treat those patients by intrathyroid injection of DEX combined with methimazole, and the function of Treg cells and balance of Th1/Th2 will be evaluated.

Detailed Summary:
Sponsor: Xiao-Ming Mao

Current Primary Outcome: 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%.


Original Primary Outcome: Function of Regulatory T Cells [ Time Frame: From baseline to 90 days ]

Function of Treg cells was 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%.


Current Secondary Outcome: 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.


Original Secondary Outcome: The proportion of Th1 and Th2 cells [ Time Frame: From baseline to 90 days ]

Th1 and Th2 cells was identified by flow cytometry analysis.


Information By: Nanjing Medical University

Dates:
Date Received: February 9, 2012
Date Started: March 2012
Date Completion:
Last Updated: November 8, 2012
Last Verified: November 2012