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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02653833
Other study ID # Pro00041688
Secondary ID
Status Terminated
Phase Early Phase 1
First received
Last updated
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
Health authority
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

Study Design


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
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