Clinical Trial: The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

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 Summary:

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.


Sponsor: Cedars-Sinai Medical Center

Current Primary Outcome: Change in Skeletal Muscle Blood Flow [ Time Frame: 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.


Original Primary Outcome: Change in Skeletal Muscle Blood Flow [ Time Frame: At baseline and within one hours after taking Ranolazine ]

Exercise induced skeletal muscle perfusion is measured by contrast-enhanced ultrasound (CEU) during graded voluntary contraction on a hand grip dynamometer.


Current Secondary Outcome:

  • Change in Measured Functional Sympatholysis [ Time Frame: 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) [ Time Frame: 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.


Original Secondary Outcome:

  • Change in Measured Functional Sympatholysis [ Time Frame: At baseline, and within an hour after taking Ranolazine ]
    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) [ Time Frame: At baseline, and within an hour after taking Ranolazine ]
    Endothelial function is assessed by measuring flow-mediated dilation (FMD) by Doppler ultrasound.


Information By: Cedars-Sinai Medical Center

Dates:
Date Received: December 14, 2015
Date Started: December 2015
Date Completion: December 2017
Last Updated: March 2, 2017
Last Verified: March 2017