Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy
NCT ID: NCT02147639
Last Updated: 2020-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
19 participants
INTERVENTIONAL
2013-10-31
2014-05-31
Brief Summary
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Detailed Description
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The baseline study involves an intake history, physical examination, and phlebotomy for blood chemistries and DNA followed by non-invasive forearm blood flow studies (Near Infrared Spectroscopy, Doppler Ultrasound) before and after a brief bout of handgrip exercise (approximately 3-5 hours to complete). Blood flow studies will be performed with the subject's lower body enclosed in an airtight chamber. Blood flow and oxygen delivery to the forearm muscles will be measured before and during application of lower body negative pressure at rest and during handgrip exercise. Lower body negative pressure simulates the blood flow changes that normally occur when a person sits up after lying down.
The results of the baseline study will determine which patients meet preset eligibility criteria to participate in the medication phase of the study. These criteria include (1) normal kidney and liver function tests and normal BNP levels (the latter to exclude heart failure), and (2) abnormal blood flow responses to handgrip exercise.
Eligible patients will be asked to repeat the above laboratory procedures on a subsequent study day after receiving a single dose of sodium nitrate. Eligible patients will also be offered the option to repeat the above laboratory procedures on three subsequent study visits, where upon: (A) the dose of sodium nitrate is increased, (B) a placebo is ingested, and/or (C) the level of exercise in increased.
The investigators plan to enroll 20 adult men with Becker muscular dystrophy.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Sodium Nitrate
Patients will ingest a single oral dose of sodium nitrate (\~8.4 mmol)
Sodium Nitrate
Baseline
This is a baseline study visit, which will serve to assess inclusion and exclusion criteria, as well as provide untreated measurments of skeletal muscle blood flow and perfusion.
No interventions assigned to this group
Dose-escalation trial
This is an optional study visit, where subjects will ingest twice the dose of sodium nitrate (\~16.8 mmol).
Sodium Nitrate - double dose
Placebo-control trial
This is an optional study visit, where patients will ingest a placebo.
Placebo
Increased exercise intensity
This is an optional study visit, where patients will be asked to repeat all of the blood flow assessments, but the exercise intensity will be increased.
Increased exercise intensity
Interventions
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Sodium Nitrate
Sodium Nitrate - double dose
Placebo
Increased exercise intensity
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of hypertension or blood pressure averaging ≥140/90 mmHg
* Diabetes mellitus or other systemic illness
* Heart failure by clinical exam, elevated BNP, or heart failure medication
* Serum creatinine ≥ 1.5 mg/dL
* Any history of substance abuse (including alcohol)
* Any history of psychiatric illness
15 Years
45 Years
MALE
No
Sponsors
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Cedars-Sinai Medical Center
OTHER
Responsible Party
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Principal Investigators
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Ronald G Victor, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center
Locations
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Cedars-Sinai Heart Institute
Los Angeles, California, United States
Countries
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Other Identifiers
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NANO3
Identifier Type: -
Identifier Source: org_study_id
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