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

Phase 1

Completed

• Conditions: Graves' Disease
• Interventions: Drug: Dexamethasone

• Registration Number: NCT01534169
• Lead Sponsor: Xiao-Ming Mao

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 Description

Not available

Study Timeline

• Study First Submitted: 2012-02-09
• Study First Submitted QC: 2012-02-15
• Study First Posted: 2012-02-16
• Study Start: 2012-03
• Primary Completion: 2012-03
• Status Verified: 2012-11
• Study Completion: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Function of Regulatory T Cells	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%.

Secondary Outcome Measures

Name	Time	Method
The proportion of Th1 and Th2 cells	From baseline to 90 days	Th1 and Th2 cells will be identified by flow cytometry analysis.

Trial Locations

Locations (1)

Nanjing First Hospital Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China