Muscular Dystrophy
Conditions
Keywords
Becker, Muscular Dystrophy, Skeletal Muscle, blood flow, Ultrasound
Brief summary
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.
Detailed description
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.
Interventions
OTHERbeetroot juice extract
Blood flow to the forearm is visualized via an ultrasound technique at rest and with graded exercise. The experiment is then repeated shortly after the subject takes the study agent, beetroot juice extract.
DRUGTadalafil 20 MG
Blood flow to the forearm is visualized via an ultrasound technique at rest and with graded exercise. The experiment is then repeated shortly after the subject takes the study agent, beetroot juice extract.
Sponsors
Cedars-Sinai Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Skeletal Muscle Blood Flow | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Measured Functional Sympatholysis | At baseline, and within an hour after taking beetroot juice or Tadalafil | Functional sympatholysis (attenuation of exercise induced skeletal muscle vasoconstriction) is assessed using a lower body negative pressure chamber. |
| Change in Measured Flow Mediated Dilation (FMD) | At baseline, and within an hour after taking beetroot juice or Tadalafil | Endothelial function is assessed by measuring flow-mediated dilation (FMD) by Doppler ultrasound. |
Countries
United States
Outcome results
None listed