Effects of Levothyroxine on Endothelial Function of Patients With Subclinical Hypothyroidism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change from baseline flow-mediated dilation at 2 months
研究概览
简要总结
Hypothyroidism is risk factor in atherosclerotic cardiovascular diseases, but there is a controversy in effect of subclinical hypothyroidism on cardiovascular diseases. We aim to estimate the relation between subclinical hypothyroidism and endothelial dysfunction and the effects of levothyroxine therapy on it. Patients with confirmed subclinical hypothyroidism by lab results will be randomized to two groups of treatment with one daily dose of 100 mg Levothyroxine or placebo. The flow-mediated dilation and intima media thickness are evaluated before and after the study.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65
- •confirmed subclinical hypothyroidism
排除标准
- •receiving of other treatments for hypothyroidism
- •patients with other major medical disorders
- •hyperlipidemia
研究组 & 干预措施
Placebo
In the placebo group treatment regimen and advices are identical to that of the treatment group, except for using a pharmacologically neutral agent, with complete resemblance to the real treatment.
干预措施: Placebo (Drug)
Levothyroxin
In the treatment group, daily doses of 100 mg of Levothyroxine will be administered every morning, half an hour before breakfast.
干预措施: Levothyroxine (Drug)
结局指标
主要结局
Change from baseline flow-mediated dilation at 2 months
时间窗: At baseline and then 2 months after treatment
Flow-mediated dilation will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
Change from baseline intima-media thickness at 2 months
时间窗: At baseline and then 2 months after treatment
Intima-media thickness will be assessed using standard method with a radiologist unaware to the study arms at baseline and then 2 months after treatment.
次要结局
未报告次要终点
研究者
Nasmi Niknam
Dr.
Isfahan University of Medical Sciences