Clinical trial NCT01534169: Function of Regulatory T Cells Improved by Dexamethasone in Graves' Patients
Official title: Function of Regulatory T Cells Improved by Treatment With an Intrathyroid Injection of Dexamethasone in Graves' Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Graves' Disease
Keywords: Graves' disease
Dexamethasone
Function of regulatory T cells
The proportion of Th1 and Th2 cells
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* GD patients will have been trated with methimazole and serum levels of TSH and FT4 should be in the normal range.

Exclusion Criteria:

* Pregnancy
* Allergy to antithyroid drugs (ATD)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels more than two times the upper normal range
* Patients with coexistent endocrine or organ-specific autoimmune diseases (such as those with atopic dermatitis or bronchial asthma)
* Patients taking medications that could affect the immune system (such as corticosteroids), noncompliance because of psychiatric or other serious diseases
* Unwillingness to participate in the study.

Primary outcomes:
measure: Function of Regulatory T Cells
timeFrame: From baseline to 90 days
Secondary outcomes:
measure: The proportion of Th1 and Th2 cells
timeFrame: From baseline to 90 days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital Affiliated to Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital Affiliated to Nanjing Medical University
name: Xiao-Ming Mao, MD.
role: STUDY_CHAIR
References:
citation: Mao XM, Li HQ, Li Q, Li DM, Xie XJ, Yin GP, Zhang P, Xu XH, Wu JD, Chen SW, Wang SK. Prevention of relapse of Graves' disease by treatment with an intrathyroid injection of dexamethasone. J Clin Endocrinol Metab. 2009 Dec;94(12):4984-91. doi: 10.1210/jc.2009-1252. Epub 2009 Oct 22.
citation: Hu Y, Tian W, Zhang LL, Liu H, Yin GP, He BS, Mao XM. Function of regulatory T-cells improved by dexamethasone in Graves' disease. Eur J Endocrinol. 2012 Apr;166(4):641-6. doi: 10.1530/EJE-11-0879. Epub 2012 Jan 4.