NCT02295202已完成4 期
Impact of Obstructive Sleep Apnea Treatment in Patients With Metabolic Syndrome: A Randomized Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Reversibility of Metabolic Syndrome criteria
研究概览
简要总结
Obstructive Sleep Apnea (OSA) is a common condition that may induce hemodynamic and metabolic dysregulation. However, it is not clear if OSA is a mere epiphenomenon or contributes to increase the morbidity associated with metabolic syndrome. This study was designed to evaluate the impact of OSA treatment with CPAP in consecutive patients with metabolic syndrome.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Metabolic Syndrome (ATP III)
- •Moderate to severe OSA
排除标准
- •Patients under chronic use of medications
- •Neurological diseases
- •Coronary artery disease
- •Acute heart failure
- •Chronic renal failure (GFR < 30 ml/min)
- •Chronic obstructive pulmonary disease
- •Mild OSA and patients with BMI over 40 kg/m2.
结局指标
主要结局
Reversibility of Metabolic Syndrome criteria
时间窗: 6 months
次要结局
- Hepatic steatosis(6 months)
- coronary atherosclerosis(6 months)
- Abdominal fat(6 months)
- Inflammatory markers(6 months)
- MicroRNAs(6 months)
- endothelial function(6 months)
- Metabolomics(6 months)
- Heart remodeling(6 months)
- carotid intima-media thickness(6 months)
- Epicardic fat(6 months)
研究者
Luciano F Drager, MD, PhD
Luciano F. Drager
University of Sao Paulo
研究点 (1)
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