Effects of L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Hypothyroidism

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism

Conditions
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Hypothyroidism, Thyroid Diseases, Endocrine System Diseases

Intervention / Treatment
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* Drug: L-thyroxine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: L-thyroxine<br>Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period | Drug: L-thyroxine<br> <br> * Other names: Euthyrox;|
| No Intervention: blank<br>No intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality |  | endpoint of the trail | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronavirus disease 2019 (COVID-19), Hypothyroidism, Lipid, Atherosclerosis, Oxidative Stress, Chronic Inflammation, Endothelial Function, Adipocytokine, L-thyroxine