Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Skeletal Muscle Blood Flow
研究概览
简要总结
This pilot study tests the hypothesis that the medication nitric oxide extract from beetroot juice improves blood flow to the skeletal muscle during exercise. The investigators will use cutting edge technology with contrast enhanced ultrasound to visualize the microvascular blood supply to the forearm. Animal studies have shown reversal of muscle damage with improved delivery of blood to the exercising muscle. This research aims to understand the mechanism of action of this medication in a way it has never been studied before. The results may help benefit individuals with muscular Dystrophy in the future.
详细描述
The subjects are asked to perform a graded hand-grip exercise while blood flow to the skeletal muscle is visualized by contrast enhanced ultrasound.
This is done at baseline and after taking the study agent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy man, aged 18 to 45 years, currently taking no medication. OR
- •Clinical diagnosis of Becker Muscular Dystrophy (BMD), aged 18 to 45 years, and currently taking no medication.
排除标准
- •Hypertension, diabetes, heart failure, liver disease
- •ECG evidence of prolonged QT interval
研究组 & 干预措施
Healthy Controls (HC)
Healthy men currently taking no medications will be asked to perform graded hand-grip exercise while a contrast enhanced ultrasound (CEU) probe is placed over their forearm to measure blood flow. This is repeated at baseline and shortly after taking beetroot juice extract.
干预措施: Tadalafil 20 MG (Drug)
Healthy Controls (HC)
Healthy men currently taking no medications will be asked to perform graded hand-grip exercise while a contrast enhanced ultrasound (CEU) probe is placed over their forearm to measure blood flow. This is repeated at baseline and shortly after taking beetroot juice extract.
干预措施: beetroot juice extract (Other)
Becker Muscular Dystrophy (BMD)
currently taking no medications will be asked to perform graded hand-grip exercise while a contrast enhanced ultrasound (CEU) probe is placed over their forearm to measure blood flow. Using a lower body negative pressure (LBNP) chamber, the subjects are tested for impaired exercise induced vasodilation to the skeletal muscle or "functional sympatholysis". This is repeated at baseline and shortly after taking beetroot juice extract.
干预措施: Tadalafil 20 MG (Drug)
Becker Muscular Dystrophy (BMD)
currently taking no medications will be asked to perform graded hand-grip exercise while a contrast enhanced ultrasound (CEU) probe is placed over their forearm to measure blood flow. Using a lower body negative pressure (LBNP) chamber, the subjects are tested for impaired exercise induced vasodilation to the skeletal muscle or "functional sympatholysis". This is repeated at baseline and shortly after taking beetroot juice extract.
干预措施: beetroot juice extract (Other)
结局指标
主要结局
Change in Skeletal Muscle Blood Flow
时间窗: At baseline and within one hours after taking beetroot juice or Tadalafil
Exercise induced skeletal muscle perfusion is measured by contrast-enhanced ultrasound (CEU) during graded voluntary contraction on a hand grip dynamometer.
次要结局
- Change in Measured Functional Sympatholysis(At baseline, and within an hour after taking beetroot juice or Tadalafil)
- Change in Measured Flow Mediated Dilation (FMD)(At baseline, and within an hour after taking beetroot juice or Tadalafil)