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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01848171
• Other study ID #: 20130328
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: July 2013
• Est. completion date: July 2023

Study information

• Verified date: May 2022
• Source: Shandong Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 700
• Est. completion date: July 2023
• Est. primary completion date: July 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atherosclerosis
• Endocrine System Diseases
• Hypothyroidism
• Thyroid Diseases

Intervention

Drug:
• L-thyroxine

Locations

Country	Name	City	State
China	Shandong Provincial Hospital	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality		endpoint of the trail
Secondary	Change in Serum Lipid Levels		baseline, 3 months, 6 months, every 12 months during the following follow-up period until the trial is completed
Secondary	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
Secondary	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
Secondary	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