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

Phase 4

• Conditions: Hypothyroidism; Thyroid Diseases; Endocrine System Diseases
• Interventions: Drug: L-thyroxine

• Registration Number: NCT01848171
• Lead Sponsor: Shandong Provincial Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-05-02
• Study First Submitted QC: 2013-05-02
• Study First Posted: 2013-05-07
• Study Start: 2013-07
• Status Verified: 2022-05
• Last Update Submitted: 2023-01-15
• Last Update Posted: 2023-01-18
• Primary Completion: 2023-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 700

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-thyroxine	L-thyroxine	Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period

Primary Outcome Measures

Name	Time	Method
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality	endpoint of the trail

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Shandong Provincial Hospital; 🇨🇳 Jinan, Shandong, China