The Beneficial Effect of L-Thyroxine Long -Term Replacement on Lipid Profiles and Atherosclerosis in Subclinical Hypothyroidism: A Prospective Study
试验速览
- 阶段
- 4 期
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- change in thickness of blood vessel wall
研究概览
简要总结
Subclinical hypothyroidism (SCH) is a common condition affecting 3-10% of the general population, especially in women older than 50 years old. It is controversial whether SCH can lead to increased risks of cardiovascular (CV) disease and whether treatment with L-thyroxine reverses these risks. The present study was designed to evaluate the effect of L-thyroxine treatment in SCH on lipid profile, atherosclerosis, endothelial function, serum inflammatory factors and adipocytokines.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female aged of 18 to 60 years old;
- •Diagnosis was subclinical hypothyroidism(elevated serum thyroid-stimulating hormone levels with normal serum free T4 levels measured at least two times with a three-month interval);
- •untreated.
排除标准
- •Pregnancy or lactation women;
- •Presence of pituitary/hypothalamic disorders, diabetes mellitus or other endocrinal and metabolic disorders;
- •Presence of psychological or physical disabilities,acute infection, cerebrovascular or cardiovascular disease, chronic respiratory disease and other illnesses known to alter lipid metabolism;
- •Taking lipid-lowering agents and other drugs that known to influence thyroid function, blood pressure, heart function or bile acids;
- •Obviously poor compliance.
研究组 & 干预措施
L-thyroxine
Oral administration, starting dose 25 or 50 micrograms once daily.
干预措施: L-thyroxine (Drug)
结局指标
主要结局
change in thickness of blood vessel wall
时间窗: measured at baseline; 6 months; 12 months and 24 months.
change in lipid profile
时间窗: measured at baseline; 6 month; 12 months and 24 months.
次要结局
- change in endothelial function(measured at baseline; 6 months; 12 months and 24 months.)
- change of adipocytokines(measured at baseline; 6 months; 12 months and 24 months.)
- Change of Oxidative Stress and Chronic Inflammatory Factors Related with Atherosclerosis(measured at baseline; 6 months; 12 months and 24 months.)
研究者
Ling Gao
Professor
Shandong Provincial Hospital