Muscular Dystrophy Clinical Trial
Official title:
Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
Verified date | June 2019 |
Source | Cedars-Sinai Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 6 |
Est. completion date | September 1, 2018 |
Est. primary completion date | September 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - Hypertension, diabetes, heart failure, liver disease - ECG evidence of prolonged QT interval |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Skeletal Muscle Blood Flow | Exercise induced skeletal muscle perfusion is measured by contrast-enhanced ultrasound (CEU) during graded voluntary contraction on a hand grip dynamometer. | At baseline and within one hours after taking beetroot juice or Tadalafil | |
Secondary | Change in Measured Functional Sympatholysis | Functional sympatholysis (attenuation of exercise induced skeletal muscle vasoconstriction) is assessed using a lower body negative pressure chamber. | At baseline, and within an hour after taking beetroot juice or Tadalafil | |
Secondary | Change in Measured Flow Mediated Dilation (FMD) | Endothelial function is assessed by measuring flow-mediated dilation (FMD) by Doppler ultrasound. | At baseline, and within an hour after taking beetroot juice or Tadalafil |
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