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RecruitingNCT05043233Updated Sep 14, 2021

Observation in the Treatment of Graves' Disease

An observational study in Patient Acceptance of Health Care, sponsored by Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-09-14.

Sponsored by Shanghai Jiao Tong University School of Medicine · Observational

From the registry’s dates

  • Primary completion was expected by Oct 2024, 2 years ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Graves' disease is the main cause of clinically hyperthyroidism, accounting for about 75% to 80%, and it occurs in women of childbearing age. Clinical manifestations include: high eating, weight loss, sweating, palpitations, emotional excitement and other high metabolism Syndrome. Some patients may have manifestations such as infiltrating exophthalmos and pretibial mucinous edema.

Graves' disease is an organ-specific autoimmune disease characterized by the production of a specific antibody TRAb against thyroid stimulating hormone receptor (TSHR). TRAb can mimic the role of thyroid stimulating hormone, combined with TSHR, stimulating TRAb can cause continuous activation of cAMP, resulting in increased production and release of thyroid hormone. Excessive thyroid hormones in the circulation act on body tissues to cause hypermetabolism and goiter. The pathogenesis of Graves' disease is currently unclear. The three major factors of genetics, environment and immunity are involved in the onset of Graves' disease. There is no doubt that the immune factor is an important factor in the pathogenesis of Graves' disease hyperthyroidism. Studies have shown that CD4+ T cells play an important role in Graves disease. CD4+ T lymphocytes can accept antigens presented by antigen presenting cells, secrete cytokines and assist B lymphocytes to differentiate into plasma cells and produce antibodies. CD4+T accounts for about 40% to 60% of peripheral T cells and can be differentiated into various T cell subsets such as Th1, Th2, Th17, Th22, Th9 and Treg cells. Treg cells are regulatory T cells, mainly involved in the negative regulation of inflammation. Recent researches suggest that the decrease in Treg cell number or loss of function is related to the pathogenesis of various autoimmune diseases. The investigators' previous study showed that the proportion of Treg cells in peripheral blood mononuclear cell of patients with initial Graves' disease was significantly lower than that of healthy controls, and it was negatively correlated with TRAb levels. At the same time, studies have shown that in the early stage of Graves' disease, the number of pDC cells as the main antigen presenting cells has increased. In vitro studies have confirmed that pDC secretes IFN-α to induce differentiation of naive T cells and interferes with the normal immunosuppression of Treg cells. Function, induce apoptosis of Treg cells. Therefore, the weakened immunosuppressive effect of Treg cells also plays a role in the pathogenesis of Graves' disease.

Graves' disease is an autoimmune disease, but the current treatments for Graves' disease: antithyroid drugs, radioactive 131I, surgery, but there is no treatment method through direct immune modulation. Surgery and radioactive 131I treatment achieve rapid cure by removing or damaging the thyroid gland. Surgery is invasive treatment. There are neurovascular injury and anesthesia complications. Most patients with secondary thyroid dysfunction after radioactive 131I treatment require oral L-T4 for life.Compared with the other two methods, antithyroid drug treatment has the advantages of non-invasiveness, convenience, and ease of acceptance by patients, but it has the problems of long treatment duration, low remission rate, and easy recurrence. It also has the induction of agranulocytosis, liver function damage, and rash.

However, there are still few observational follow-up studies on Graves' disease in China, and there are few research reports in this regard.

02

Conditions studied

  • Patient Acceptance of Health Care

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03

In context

Graves Disease

150 studies on the registry are indexed under Graves Disease; 53 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 110 across 57 observational studies indexed under Graves Disease.

Browse Graves Disease studies →

Lead sponsor

Shanghai Jiao Tong University School of Medicine is the lead sponsor of 358 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

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.

  1. High metabolic symptoms such as fear of heat, sweating, and palpitations;
  2. Diffuse enlargement of thyroid gland, B-ultrasound of thyroid gland indicates diffuse thyroid disease and increased blood flow of thyroid;
  3. Serological detection of TSH levels decreased and FT3 and/or FT4 increased; meanwhile, TRAb was positive (TRAb>1.75 IU/L);
  4. Accompanied by thyroid infiltrating ocular signs or pretibial mucous edema.

Exclusion criteria

Exclusion Criteria:

  1. Patients with Graves' disease who have previously undergone radioactive iodine 131 or surgery;
  2. Blood routine WBC\<3×109/L, neutrophils\<1.5×109/L, or accompanied by other malignant blood diseases;
  3. Patients with other serious heart, liver, lung, kidney disease or malignant tumors;
  4. 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.;
  5. 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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • DrugMethimazole(MMI)

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

06

What researchers measure

Primary outcomes

  1. change in TRAb level (IU/L)

    Time frame: 12 weeks

  2. Predict the risk of recurrence before the start of antithyroid drug therapy

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. change in FT3 level (pmol/L)

    Time frame: 12 weeks

  2. change in FT4 level (pmol/L)

    Time frame: 12 weeks

  3. change in TSH level (uIUm/L)

    Time frame: 12 weeks

  4. change in TSI level (IU/L)

    Time frame: 12 weeks

07

Study locations

1 of 1 sites recruiting
  • Ruijin hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200025, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05043233
Lead sponsor
Shanghai Jiao Tong University School of Medicine
Responsible party
Wang Weiqing (Clinical Professor, Shanghai Jiao Tong University School of Medicine) — Principal investigator
First posted
Sep 14, 2021
Start date
Oct 1, 2020
Primary completion
Oct 1, 2024 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Sep 14, 2021

Study contacts

Yulin Zhou, MD,PhD
Contact
yulinzhou6@163.com
8621-64370045 ext. 665344
Shu Wang, MD,PhD
Contact
shuwang999@hotmail.com
8621-64370045 ext. 665344
Weiqing Wang, MD,PhD
principal investigator · Shanghai Jiao Tong University School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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