NCT02653833

The Study of Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

Skeletal Muscle Blood Flow in Becker Muscular Dystrophy

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Muscular Dystrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-11-01
• Primary completion: 2018-09-01
• Completion: 2018-09-01
• First posted: 2016-01-12
• Last updated: 2020-01-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study