TSI and Its Relationship With Graves' Disease Relapse

Graves Disease Clinical Trial

Official title:

Thyroid-stimulating Immunoglobulins Level in Patients With Graves' Disease Undergoing Maintenance-dose of Antithyroid Drug and Its Relationship With Disease Relapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05713097
• Other study ID #: TSI_Medic
• Status: Completed
• Start date: January 2, 2022
• Est. completion date: August 31, 2022

Study information

• Verified date: February 2023
• Source: University of Medicine and Pharmacy at Ho Chi Minh City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: August 31, 2022
• Est. primary completion date: August 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Graves Disease
• Thyroid Diseases

Intervention

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

Locations

Country	Name	City	State
Vietnam	Hoa Hao Clinic	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
University of Medicine and Pharmacy at Ho Chi Minh City

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with GD relapse	Patients who had relapse of hyperthyroidism due to GD	at least 1 year after ATD withdrawal
Secondary	TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.	TSI level before planning for ATD withdrawal	before ATD withdrawal
Secondary	Optimal cut-off of TSI level for predicting GD relapse	Optimal cut-off of TSI level before ATD withdrawal for predicting GD relapse	before ATD withdrawal