TSI and Its Relationship With Graves' Disease Relapse

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

Total Enrollment

352 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-02

Study Completion Date

2022-08-31

Brief Summary

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The goal of this observational study is to determine the role of TSI, as well as clinical signs and thyroid function tests in predicting Graves' disease (GD) relapse after withdrawing anti thyroid drug (ATD). The main questions it aims to answer are:

1. To investigate the serum TSI concentration in patients with GD undergoing maintenance-dose ATD.
2. To determine an optimal cut-off of TSI level for predicting GD relapse.
3. To determine the role of TSI in predicting Graves' disease relapse after withdrawing ATD.

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Detailed Description

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Retrospective follow-up study of patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City from January 2000 to April 2021. TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician). ATD withdrawal would be planned when patients achieved euthyroid status clinically with normal FT4 tests for at least 3 months with minimal dose of ATD. The decision was also based on TSI concentration, goiter's characteristics and parenchymal vascularity on Doppler ultrasound.

Conditions

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Graves Disease Immunoglobulin Anti-Thyroid Antibodies Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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ATD withdrawal

ATD treatment was decided to be stopped at the discretion of the attending physician. Then, patients were followed after ATD withdrawal to determine who would have relapse of GD.

Finally, patients were divided into 2 groups: Relapse and No relapse

TSI

Intervention Type DIAGNOSTIC_TEST

TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).

No ATD withdrawal

Patients treated with ATD still the end of the study

TSI

Intervention Type DIAGNOSTIC_TEST

TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).

Interventions

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TSI

TSI was measured several times during the course of treatment when planning to stop medication (at the discretion of the attending physician).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients diagnosed with hyperthyroidism due to Graves' disease according to the criteria of the Japan Thyroid Association.
* TSI: measured during the course of treatment when planning to stop medication (normal FT4 at maintenance-dose of ATD) Methimazole (MMI): at doses of ≤10 mg. Propylthiouracil (PTU): at doses of ≤200 mg.

Exclusion Criteria

* Hyperthyroidism due to other causes
* Patients who were intolerant to ATD or had serious side effects with ATD.
* TSIs were measured in pregnancy.
* Patients treated with surgery or radioactive iodine.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No