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

Sponsor

Xiao-Ming Mao (Other)

Overall Status

Completed

CT.gov ID

NCT01534169

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

6.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graves' Disease	Drug: Dexamethasone	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Actual Primary Completion Date :

Mar 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isotonic Na chloride The treatment strategy is the same with intervention, only the drug (dexamethasone) will be changed to isotonic Na chloride.	Drug: Dexamethasone 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 Names: Hexadecadrol

Arm

Intervention/Treatment

Experimental: Isotonic Na chloride

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

Drug: Dexamethasone

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 Names:

Hexadecadrol

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts 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.