Effects of Long-term L-thyroxine Replacement on Serum Lipid and Atherosclerosis in Patients With Hypothyroidism
试验速览
- 阶段
- 4 期
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •40~75 years old
- •Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months
排除标准
- •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.
研究组 & 干预措施
L-thyroxine
Oral administration, tablets, starting dose 25 or 50 micrograms once daily, during the follow-up period
干预措施: L-thyroxine (Drug)
结局指标
主要结局
Rate of First cardiovascular disorder (CVD) Events, CVD Mortality and All-cause Mortality
时间窗: endpoint of the trail
次要结局
- 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)
研究者
Jia-jun Zhao
Professor
Shandong Provincial Hospital