TSI and Its Relationship With Graves' Disease Relapse

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

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.

Study Overview

• Status: Completed
• Conditions: Graves Disease; Immunoglobulin; Anti-Thyroid Antibodies Disorder
• Intervention / Treatment: Diagnostic test: TSI

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 352

Contacts and Locations

Study Locations

• Vietnam
  • Ho Chi Minh City, Vietnam, 70000
    • Hoa Hao Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with hyperthyroidism due to Graves' disease, treated at the endocrine outpatient clinic of Medic Medical Center, Ho Chi Minh City, Vietnam from January 2000 to April 2021.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	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).
No ATD withdrawal; Patients treated with ATD still the end of the study	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with GD relapse	Patients who had relapse of hyperthyroidism due to GD	at least 1 year after ATD withdrawal

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSI LEVEL IN PATIENTS WITH GRAVES' DISEASE UNDERGOING MAINTENANCE-DOSE OF ANTITHYROID DRUG.	TSI level before planning for ATD withdrawal	before ATD withdrawal
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

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City
• Investigators: Principal Investigator: Vu Nhat Phong Nguyen, MD, University of Medecine and Pharmacy at Ho Chi Minh City

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 2, 2022
• Primary Completion (ACTUAL): August 31, 2022
• Study Completion (ACTUAL): August 31, 2022

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 2, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 2, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: treatment duration; Graves' ophthalmopathy; TSI; recurrent Graves' disease; anti-thyroid drug; cut-off
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Endocrine System Diseases; Exophthalmos; Orbital Diseases; Goiter; Hyperthyroidism; Thyroid Diseases; Graves Disease
• Other Study ID Numbers: TSI_Medic

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No