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

NCT ID: NCT01534169

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-11-30

Brief Summary

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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

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Conditions

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Graves' Disease

Keywords

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Graves' disease Dexamethasone Function of regulatory T cells The proportion of Th1 and Th2 cells

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Isotonic Na chloride

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

Group Type EXPERIMENTAL

Dexamethasone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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Hexadecadrol

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xiao-Ming Mao

OTHER

Sponsor Role lead

Responsible Party

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Xiao-Ming Mao

Professor, MD.

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Xiao-Ming Mao, MD.

Role: STUDY_CHAIR

Nanjing First Hospital Affiliated to Nanjing Medical University

Locations

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Nanjing First Hospital Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

Site Status

Countries

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China

References

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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.

Reference Type RESULT
PMID: 19850691 (View on PubMed)

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.

Reference Type RESULT
PMID: 22219499 (View on PubMed)

Other Identifiers

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HDJP-H200829

Identifier Type: -

Identifier Source: org_study_id