The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

Muscular Dystrophy Clinical Trial

Official title:

Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02653833
• Other study ID #: Pro00041688
• Status: Terminated
• Phase: Early Phase 1
• Start date: November 1, 2017
• Est. completion date: September 1, 2018

Study information

• Verified date: June 2019
• Source: Cedars-Sinai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Muscular Dystrophies
• Muscular Dystrophy
• Muscular Dystrophy, Duchenne

Intervention

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.

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

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