A Clinical Follow-up Study on Drug Therapy for Graves' Disease Patients in China

NCT ID: NCT07040306

Last Updated: 2025-07-09

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

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-14

Study Completion Date

2030-12-01

Brief Summary

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This study was a prospective follow-up study of newly diagnosed and relapsed Graves' disease patients in the Endocrinology Clinic of the First Affiliated Hospital of China Medical University. The following aspects will be studied: 1. Through the prospective follow-up study of GD patients, we will get the relapse rate and remission rate of GD patients treated with drugs, explore the risk factors of GD patients relapsing after drug treatment, and make GD relapse risk prediction software; 2. To compare the effects of high dose and low dose methimazole on the remission rate, liver side effects, leukopenia and other adverse drug reactions, and to summarize the incidence and risk factors of liver side effects, leukopenia and other adverse drug reactions caused by drug treatment; 3. To investigate the sensitivity and specificity of TRAb in the diagnosis of GD in China and its role in predicting recurrence; 4. After taking ATD, the serum alkaline phosphatase of GD patients will increase first and then decrease. This study will focus on analyzing the dynamic changes of this index before and after methimazole treatment, and analyze the relationship between it and thyroid function index.

Detailed Description

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Conditions

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Graves´ Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Methimazole(MMI)

Determine the enrolled GD patients and adjust the dosage of methimazole according to the 2016 American Thyroid Association guidelines. Conduct thyroid function, liver function, TRAb, and blood routine tests during outpatient follow-up to observe the treatment effect and provide medication guidance.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Age ≥18 years old.
2. Newly diagnosed GD and GD relapses.

Exclusion Criteria

1. Patients with active infiltrative exophthalmos in GD were excluded.
2. Patients with other autoimmune diseases affecting thyroid function were excluded.
3. Excluding patients with combined malignancies and other serious diseases.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Hospital of China Medical University

OTHER

Sponsor Role lead

Responsible Party

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Xiaochun Teng

Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiaochun Teng, Medical Doctor (MD)

Role: CONTACT

+8613704049020

Facility Contacts

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Xiaochun Teng, Medical Doctor (MD)

Role: primary

+8613704049020

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2019-222

Identifier Type: -

Identifier Source: org_study_id

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