Observation in the Treatment of Graves' Disease

NCT05043233 | Unknown DMC

• 1 other identifier: 132563
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

At present, there are still few observational studies on Graves' disease in China, and there are few research reports in this regard. In order to further carry out high-quality observational follow-up research on Graves' disease hyperthyroidism, including establishing standard diagnosis and treatment procedures, providing data support for the establishment of research protocols such as sample size and follow-up time estimation, this study was conducted at Ruijin Hospital, Shanghai Jiaotong University School of Medicine. The endocrinology clinic carried out the registration follow-up study of Graves' disease.

Conditions

Patient Acceptance of Health Care

Outcome Measures

Primary Outcomes (2)

• change in TRAb level (IU/L)

  12 weeks

• Predict the risk of recurrence before the start of antithyroid drug therapy

  through study completion, an average of 1 year

Secondary Outcomes (4)

• change in FT3 level (pmol/L)

  12 weeks

• change in FT4 level (pmol/L)

  12 weeks

• change in TSH level (uIUm/L)

  12 weeks

• change in TSI level (IU/L)

  12 weeks

Study Arms (1)

Patients with Graves' disease

Graves' disease was diagnosed based on clinical symptoms and laboratory findings. The clinical symptoms included heat intolerance, fatigue, increased appetite, increased sweating, weight loss, muscle weakness, tremors, and diffusely enlarged thyroid glands. The laboratory results included increased serum concentrations of free thyroxine (FT4) and/ or free triiodothyronine (FT3), decreased basal thyroid-stimulating hormone (TSH) level, and TRAb positivity. All participants in this study would be treated with anti-thyroid drugs(MMI: methimazole) according to the 2016 ATA guildline.

Drug: Methimazole(MMI)

Interventions

Methimazole(MMI) DRUG

Methimazole is a widely used antithyroid drug and is often used in the treatment of Graves' disease hyperthyroidism

Patients with Graves' disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The research object comes from the outpatients of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine. The recruitment site is the Department of Endocrinology of Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine.

You may qualify if:

• Patients aged 18-70 years old with normal BMI (18-25), who are diagnosed with Graves' disease hyperthyroidism in accordance with the 2016 American Thyroid Association's guidance at the first diagnosis, or patients who relapse after more than one year of medication withdrawal.
• High metabolic symptoms such as fear of heat, sweating, and palpitations;
• Diffuse enlargement of thyroid gland, B-ultrasound of thyroid gland indicates diffuse thyroid disease and increased blood flow of thyroid;
• Serological detection of TSH levels decreased and FT3 and/or FT4 increased; meanwhile, TRAb was positive (TRAb\>1.75 IU/L);
• Accompanied by thyroid infiltrating ocular signs or pretibial mucous edema.

You may not qualify if:

• Patients with Graves' disease who have previously undergone radioactive iodine 131 or surgery;
• Blood routine WBC\<3×109/L, neutrophils\<1.5×109/L, or accompanied by other malignant blood diseases;
• Patients with other serious heart, liver, lung, kidney disease or malignant tumors;
• In the past six months, there is a history of using immunosuppressants or other autoimmune diseases such as systemic lupus erythematosus, Sjogren's syndrome, etc.;
• Pregnant and lactating women; Allergies to the drugs used in the treatment plan; and any situation (medical, psychological, social, or geographical factors) that may endanger the safety of the patient or prevent the patient from successfully participating in the study.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Ruijin hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

In the study, peripheral venous blood samples form paitents at 3 time points during follow-up(untreated, euthyorid status, and TRAb-neative status). Collection requirements: about 10ml venous blood should be collected by anticoagulant vacuum negative pressure blood collection vessel while the patient does not need to be fasting. Then their clinical parameters, including thyrotropin (TSH), free T3 (FT3), free T4 (FT4), thyroperoxidase antibody (TPOAb), thyroglobulin antibody (TgAb) and thyrotropin receptor antibody (TRAb) levels, thyroid-stimulating immunoglobulin (TSI) were measured by routine clinical laboratory methods.

MeSH Terms

Conditions

Patient Acceptance of Health Care

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Weiqing Wang, MD,PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yulin Zhou, MD,PhD

CONTACT

8621-64370045; yulinzhou6@163.com

Shu Wang, MD,PhD

CONTACT

8621-64370045; shuwang999@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 14, 2021
• Study Start: October 1, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)