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The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

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ClinicalTrials.gov Identifier: NCT02653833
Recruitment Status : Recruiting
First Posted : January 12, 2016
Last Update Posted : March 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ron Victor, Cedars-Sinai Medical Center

December 14, 2015
January 12, 2016
March 6, 2017
December 2015
December 2017   (Final data collection date for primary outcome measure)
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.
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.
Complete list of historical versions of study NCT02653833 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
Not Provided
Not Provided
 
The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
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.

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.

Interventional
Early Phase 1
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Muscular Dystrophy
  • Drug: Tadalafil 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.
  • Other: beetroot 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.
  • Experimental: 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.
    Interventions:
    • Drug: Tadalafil 20 MG
    • Other: beetroot juice extract
  • Experimental: 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.
    Interventions:
    • Drug: Tadalafil 20 MG
    • Other: beetroot juice extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
19
Same as current
December 2017
December 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 45 Years   (Adult)
Yes
Contact: Katie Sy 3102487641 katrina.sy@cshs.org
Contact: Mohamad Rashid, CCRC 3102488080 Mohamad.rashid@cshs.org
United States
 
 
NCT02653833
Pro00041688
No
Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: No
Plan to Share IPD: No
Ron Victor, Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
Not Provided
Principal Investigator: Ronald G Victor, MD Cedars-Sinai Medical Center
Cedars-Sinai Medical Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP