NCT02264600Unknown不适用
Oxidative Stress and Apelin Level in Willis Ekbom Disease
Acibadem University0 个研究点目标入组 30 人开始时间: 2014年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 主要终点
- Serum apelin level in WED patients and healthy controls
研究概览
简要总结
The purpose of this study is to assess apelin level in patients with Willis-Ekbom Disease (WED) as known Restless Legs Syndrome (RLS). Cardiovascular complications of WED have been reported in recent studies. Increased oxidative stress is thought to play an important role in cardiovascular complications of WED patients. Apelin is a novel described antioxidant bioactive peptide. The investigators hypothesize that patients with WED have lower plasma apelin level than healthy subjects based on presence of oxidative stress of WED.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients diagnosed as RLS/WED according to International Classification of Sleep Disorders (ICSD-3) criteria
- •Patients with idiopathic RLS/WED
- •Moderate and severe RLS/WED according to International Restless Legs Syndrome Rating Scale
- •Periodic Leg Movements Index above 5 in polysomnography record
- •BMI below 25
排除标准
- •Disorders which cause symptomatic RLS(Iron deficiency anemia, kidney failure, diabetes mellitus, pregnancy, Parkinson's disease, multiple sclerosis, neuropathy)
- •Systemic diseases which cause possible oxidative stress status (cardiovascular diseases, obesity, diabetes mellitus, use of any medical drugs especially ACE inhibitors e.g.)
- •Another sleep disorder
结局指标
主要结局
Serum apelin level in WED patients and healthy controls
时间窗: Two months
次要结局
未报告次要终点
研究者
Selda Korkmaz
Principal Investigator
Acibadem University
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