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

Xiao-Ming Mao

Status and phase: Completed; Phase 1

Conditions: Graves' Disease

Treatments: Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT01534169

HDJP-H200829

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind

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50 participants in 1 patient group

Isotonic Na chloride

Experimental group

Description:

The treatment strategy is the same with intervention, only the drug (dexamethasone) will be changed to isotonic Na chloride.

Treatment:

Drug: Dexamethasone