Endocrine System Diseases, Hypothyroidism, Thyroid Diseases
Conditions
Keywords
Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine, coronavirus disease 2019 (COVID-19)
Brief summary
Hypothyroidism is a common clinical entity which is often complicated by dyslipidemia. It is also reported increased risk for incidence of atherosclerosis and resulting coronary heart disease(CHD), heart failure(HF) and cardiovascular(CV) death. The effect of L-thyroxine replacement treatment on serum lipid and atherosclerosis is controversial in hypothyroid patients, especially in those with mild or moderate subclinical hypothyroidism. The present study was designed to investigate whether L-thyroxine replacement was effective in improving serum lipid profiles and retarding atherosclerosis progress. Studies have shown that hypothyroidism increased the risk of COVID-19 composite poor outcomes. This study also aimed to investigate whether L-thyroxine replacement therapy was effective in reducing the incidence and mortality of COVID-19, and in improving the severity of COVID-19 and COVID-19 related complications.
Interventions
DRUGL-thyroxine
Sponsors
Shandong Provincial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 40\ 75 years old * Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months
Exclusion criteria
* Pregnant or lactating women * Severe hepatic or renal dysfunction * Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism * Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism * Obviously poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality | endpoint of the trail |
Secondary
| Measure | Time frame |
|---|---|
| Change in Serum Lipid Levels | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed |
| Change in Thickness of Blood Vessel Wall | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed |
| Change in Oxidative Stress and Chronic Inflammatory Factors Associated with Atherosclerosis | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed |
| Changes in Serum Metabolome and Lipidome | baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trail is completed |
Other
| Measure | Time frame |
|---|---|
| Rate of COVID-19, COVID-19 Mortality, COVID-19 Related Complications and Severity of COVID-19 | Since January, 2023, every 6 months during the following follow-up period until the trail is completed |
Countries
China
Outcome results
None listed