Role of Nitric Oxide Coupling in Muscle Dysfunction With COPD
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Mitochondrial function
研究概览
简要总结
Skeletal muscle dysfunction is a frequent and clinically relevant systemic manifestation of Chronic Pulmonary Obstructive Disease (COPD), which is still poorly understood. Therefore, the focus of this study is on the role of a deficit in tetrahydrobiopterin and nitric oxide synthase uncoupling induced by chronic oxidative stress on metabolic and vascular abnormalities in skeletal muscle of patients suffering from COPD.
详细描述
The purpose of this study is to assess the efficacy of supplementation with tetrahydrobiopterin (BH4) for improving vascular and muscle function in patients with COPD and healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All subjects must be between the age of 18 and 85 years;
- •For the COPD cohort, patients with a diagnosis of stable COPD (i.e., those not experiencing an acute exacerbation of symptoms) and spirometric evidence of airway obstruction (FEV1 <80% predicted, FEV/FVC<0.70);
- •Ability to perform motor tests;
- •Ability to provide informed consent
排除标准
- •uncontrolled hypertension;
- •hyperlipidemia;
- •recent exacerbation;
- •Major cardiovascular event procedure (<3 months);
- •Pregnancy
- •known significant hepatic, renal disease, active substance abuse
- •contraindication to MRI, claustrophobia
研究组 & 干预措施
acute BH4/Tetrahydrobiopterin treatment
Oral supplement, Pill, 10 mg/kg of body weight
干预措施: Tetrahydrobiopterin (Drug)
Placebo
Oral supplement, Pill, Placebo pill with inert excipient
干预措施: Placebo oral tablet (Drug)
结局指标
主要结局
Mitochondrial function
时间窗: 4 hours
PCr recovery kinetics
intracellular PO2
时间窗: 4 hours
Myoglobin oxygenation
次要结局
- systemic blood markers of oxidative stress(4 hours)
- Peripheral Blood flow(4 hours)