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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiao-Ming Mao, Nanjing Medical University
ClinicalTrials.gov Identifier:
NCT01534169
First received: February 9, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Graves' Disease
Drug: Dexamethasone
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Function of Regulatory T Cells Improved by Treatment With an Intrathyroid Injection of Dexamethasone in Graves' Patients

Resource links provided by NLM:


Further study details as provided by Nanjing Medical University:

Primary Outcome Measures:
  • Function of Regulatory T Cells [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From baseline to 90 days ] [ Designated as safety issue: Yes ]
    Th1 and Th2 cells will be identified by flow cytometry analysis.


Enrollment: 50
Study Start Date: March 2012
Study Completion Date: November 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Hexadecadrol

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01534169

Locations
China, Jiangsu
Nanjing First Hospital Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China, 210006
Sponsors and Collaborators
Xiao-Ming Mao
Investigators
Study Chair: Xiao-Ming Mao, MD. Nanjing First Hospital Affiliated to Nanjing Medical University
  More Information

Publications:
Responsible Party: Xiao-Ming Mao, Professor, MD., Nanjing Medical University
ClinicalTrials.gov Identifier: NCT01534169     History of Changes
Other Study ID Numbers: HDJP-H200829
Study First Received: February 9, 2012
Last Updated: November 8, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Nanjing Medical University:
Graves' disease
Dexamethasone
Function of regulatory T cells
The proportion of Th1 and Th2 cells

Additional relevant MeSH terms:
Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014