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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

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.

Condition or disease Intervention/treatment Phase
Muscular Dystrophy Drug: Tadalafil 20 MG Other: beetroot juice extract Early Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Skeletal Muscle Blood Flow in Becker Muscular Dystrophy
Study Start Date : December 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
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.
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: 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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653833


Contacts
Contact: Katie Sy 3102487641 katrina.sy@cshs.org
Contact: Mohamad Rashid, CCRC 3102488080 Mohamad.rashid@cshs.org

Locations
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Matthew Hakimi, MD    310-248-8080    matthew.hakimi@cshs.org   
Contact: Mohamad Rashid, CCRC    3102488080    Mohamad.rashid@cshs.org   
Principal Investigator: Ronald G Victor, MD         
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Ronald G Victor, MD Cedars-Sinai Medical Center

Responsible Party: Ron Victor, Professor of Medicine and Cardiology, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT02653833     History of Changes
Other Study ID Numbers: Pro00041688
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: March 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ron Victor, Cedars-Sinai Medical Center:
Becker
Muscular Dystrophy
Skeletal Muscle
blood flow
Ultrasound

Additional relevant MeSH terms:
Muscular Dystrophies
Muscular Dystrophy, Duchenne
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Diseases
Nervous System Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents