To Investigate the Effect of 2019 Novel Coronavirus Infection on the Condition of Patients With Hyperthyroidism
- Conditions
- COVID-19Graves Disease
- Interventions
- Other: Thyroid metabolic index
- Registration Number
- NCT06204393
- Lead Sponsor
- Qilu Hospital of Shandong University
- Brief Summary
The goal of this observational study is to learn about the correlation between COVID-19 and hyperthyroidism in Patients with hyperthyroidism complicated with COVID-19. The main questions it aims to answer are：
* The main research object is Graves disease (GD) patients.
* Changes of hyperthyroidism in GD patients complicated with COVID-19
* Changes of anxiety and depression in GD patients before and after SARS-CoV-2 infection.
* The effect of psychological intervention in GD patients after COVID-19. Participants will have regular follow-upfor one year to hyperthyroidism in our hospital, and the investigators will collect the thyroid function and related examination indexes of patients in the corresponding time period.
- Detailed Description
Longitudinal analysis of GD status was performed: Three follow-up time points were identified: before COVID-19, three months and one year after recovering from COVID-19 (the first follow-up visit, the second follow-up visit. Main collection items: Hyperthyroidism symptoms, signs, hyperthyroidism complications, psychological evaluation results, other complications，blood routine, liver and kidney function, thyroid function (FT3, FT4, TSH), thyroid-related antibodies, glucose and lipid metabolism (FBG, HbA1c, TC, TG, HDL-C, LDL-C), thyroid ultrasound and hyperthyroidism medication.Through this to understand the changes of hyperthyroidism in HT patients complicated with COVID-19 and the changes of anxiety and depression in hyperthyroidism patients before and after SARS-CoV-2 infection.And the effect of psychological intervention in GD patients after COVID-19.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- According to the diagnostic criteria of hyperthyroidism in the Chinese Guidelines for the Diagnosis and Treatment of Thyroid Diseases formulated by the Chinese Society of Endocrinology of the Chinese Medical Association, the patient had been diagnosed with hyperthyroidism.
- In accordance with the diagnostic criteria of "The diagnosis and Treatment Protocol for novel coronavirus Infection (Trial version 10).
- Cases with incomplete data
- Patients with severe autoimmune diseases, hematological diseases and malignant tumors
- Immunodeficiency (e.g.AIDS, long-term use of corticosteroids or other immunosuppressive drugs leading to immunodeficiency)
- Follow-up was less than 30 days
- The results of thyroid function were less than 3 times
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description COVID-19 has a course of 6-9 days Thyroid metabolic index The symptoms and immune level of COVD-19 in this group are in the middle level. COVID-19 has a course of more than 9 days Thyroid metabolic index Theoretically, the symptoms and immune level of COVD-19 in this group are the worst. COVID-19 has a course of less than 6 days Thyroid metabolic index COVID-19 is mild in hyperthyroidism patients with short course of disease.
- Primary Outcome Measures
Name Time Method Serum FT4 were measured with chemiluminescence method. Up to 9 months FT4 in pmmol/L
Serum TPO-Ab were measured with chemiluminescence method. Up to 9 months TPO-Ab in IU/ml
Serum TTG-Ab were measured with chemiluminescence method. Up to 9 months TG-Ab in IU/ml
Assess the changes of patients' psychological state with Generalized Anxiety Disorder-7 Items Scale（GAD-7) Up to 9 months Evaluation of anxiety state by GAD-7 scale. The lowest score of DAD-7 is 0, and the highest score is 21. The higher the score, the heavier the anxiety.
Serum FT3were measured with chemiluminescence method. Up to 9 months FT3 in pmmol/L
Serum TRAb were measured with chemiluminescence method. Up to 9 months TRAb in IU/L
Assess the changes of patients' psychological state with Patient Health Questionnaire-9（PHQ-9） Up to 9 months Evaluation of depression by PHQ-9 scale. The lowest score of PHQ-9 is 0, and the highest score is 27. The higher the score, the heavier the depression.
Serum TSH were measured with chemiluminescence method. Up to 9 months TSH in µIU/mL
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Qilu Hospital of Shandong University
🇨🇳Jinan, Shandong, China