AgingNCT04351113
Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse
A study testing MITO-AO, PB-125 and Passive Leg Movement (PLM) in people with Aging and Oxidative Stress, run by Joel Trinity at 1 site in United States.
Trial summary
Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Oxidative Stress, Vascular Endothelium
- What is being tested?
- MITO-AO, PB-125 and Passive Leg Movement (PLM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age between 65-85 yrs
- Ability to sign informed consent
- Montreal cognitive assessment (MOCA) exam score greater-than or equal to 26 4. Free-living, prior to admission
Who cannot join
- Cardiac abnormalities considered exclusionary by the study physician (e.g., congestive heart failure (CHF), coronary artery disease (CAD), right-to-left shunt)
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
- Glomerular filtration rate (GFR) less-than 30 mL/min/1.73m2 or evidence of kidney disease or failure
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia greater-than 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
- Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb greater-than 18 g/dL) or thrombocytosis (platelets greater-than 400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
- Use of anticoagulant therapy (e.g., Coumadin, heparin)
Show all 27Show fewer
- Elevated systolic pressure greater-than 150 or a diastolic blood pressure greater-than 100 (treated or untreated)
- Implanted electronic devices (e.g., pacemakers, electronic infusion pumps, stimulators)
- Cancer or history of successfully treated cancer (less than 1 year) other than basal cell carcinoma
- Currently on a weight-loss diet or body mass index greater-than 35 kg/m2 (a BMI of 35 kg/m2, which includes individuals that fall into to the Class I obesity category, has been selected to improve inclusion and generalizability to a greater percentage of the general population).
- Inability to abstain from smoking for duration of study
- A history of greater-than 20 pack per year smoking
- HIV or hepatitis B or C*
- Recent anabolic or corticosteroids use (within 3 months)
- Subjects with hemoglobin or hematocrit lower than accepted lab values
- Agitation/aggression disorder (by psychiatric history and exam)
- History of stroke with motor disability
- A recent history (less-than 12 months) of GI bleed
- Depression [greater-than 5 on the 15 items Geriatric Depression Scale (GDS)]
- Alcohol abuse (greater-than 2 drinks per day) or drug abuse (inappropriate use of prescription medications or use of any illicit/illegal drugs for recreational use)
- Exercise training (greater-than 1 session of moderate to high intensity aerobic or resistance exercise/week)
- Liver disease (aspartate aminotransferase/alanine aminotransferase 2 times above the normal limit, hyperbilirubinemia)
- Respiratory disease (acute upper respiratory infection, history of chronic lung disease with resting oxygen saturation less-than 97% on room air)
- Currently taking a mitochondrial targeted antioxidant or similarly acting nutraceutical
- Unwilling to cease dietary supplements 4 weeks prior to initiation of bed rest
- Participated in similar bed rest study during last 12 months
- Any other condition or event considered exclusionary by the PI and faculty physician
Trial locations and contacts
1 site in 1 country.
About this study
Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.
Read the detailed description
Disuse following injury or during acute hospitalization is associated with a host of negative outcomes including functional deficiencies, hospital readmission, disability, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are present as a consequence of the aging process. Any additional and accelerated insult caused by disuse poses a serious health threat to these older individuals by depleting their already diminished physiological and functional reserve and hastening the onset of disability. Current strategies aimed at preserving function during disuse have focused on preserving skeletal muscle mass and strength while the critical role of the vasculature has been largely ignored. Moreover, the underlying cause of dysfunction has not been adequately addressed in humans. This disintegrated and myopic approach likely contributes to the fact that interventions capable of preserving health during disuse do not exist. The vascular and skeletal muscle systems are inextricably linked to optimal mobility through oxygen and nutrient delivery, thus, vascular dysfunction likely contributes to and exacerbates skeletal muscle deficiencies that occur during disuse. To fully understand the impact of disuse on health and mobility and develop effective countermeasures it is our contention that both the vascular and musculoskeletal systems must be examined and the root cause of the problem must be addressed. While the underlying factors leading to these accelerated losses during disuse are unknown, they appear to be mechanistically linked to oxidative stress.
The long term goal is to minimize losses in vascular and skeletal muscle function that occur during disuse in order to maintain functional reserve and avoid serious adverse events. The objective here, which is the next step in pursuit of this goal, is to determine how oxidative stress contributes to disuse-induced vascular and skeletal muscle dysfunction. It is our central hypothesis that oxidative stress triggers the accelerated declines in vascular and skeletal muscle function during disuse. To test this hypothesis and provide compelling evidence that oxidative stress is the trigger of dysfunction the investigators will utilize two novel and fundamentally distinct strategies to improve redox balance during disuse. In Aim 1, the mitochondrial targeted antioxidant (MITO-AO) mitoquinone will be administered during disuse to improve free radical scavenging at the level of the mitochondria. In Aim 2, activation of Nuclear Factor Erythroid-2-like 2 (Nrf2) the "master regulator of antioxidant enzymes" will be accomplished with PB125 (a novel naturally occurring Nrf2 activator) to augment endogenous antioxidant defense systems. The impact of these interventions on measures of isolated and integrated vascular and skeletal muscle function before and after disuse will be examined. The central hypothesis is supported by preliminary data reporting substantial losses in vascular and skeletal muscle function and concomitant increases in oxidative stress following 5 days of bed rest. Importantly, MITO-AO prevents disuse-induced losses in muscle mass and restores age-related deficits in vascular function in aged animals and humans (preliminary data). Additionally, PB125 activates the Nrf2 pathway at multiple control points resulting in prolonged and amplified activation and subsequent gene expression of key antioxidant enzymes leading to a decrease in oxidative stress in humans (preliminary data).
- Conditions
- Aging, Oxidative Stress, Vascular Endothelium, Skeletal Muscle, Antioxidants
- Being tested
- MITO-AO, PB-125, Placebo, Passive Leg Movement (PLM), Plantar flexion
- Keywords
- Aging, cardiovascular degeneration, Muscular atrophy
- Medical subject headings
- Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MITO-AODietary supplement
Participants will receive 160 mg with breakfast on day 1 of bed rest and 40 mg with breakfast on days 2-5.
PB-125Dietary supplement
Participants will receive 100 mg on days 1-5 of bed rest.
PlaceboOther
Participants will receive Placebo on days 1-5 of bed rest.
Passive Leg Movement (PLM)Other
Participants will be tested for passive leg movement on baseline day 1, bed rest day 1, and post bed rest.
Plantar flexionOther
Participants will undergo plantar flexion on baseline day 2, pre bed rest, and post bed rest.
Isometric knee extensor testOther
Participants will undergo isometric knee extension on baseline day 2, pre bed rest, and post bed rest.
Bed restOther
Participants will undergo 5 days bed rest after 5 day baseline assessments
| Study group | Role | What they receive |
|---|---|---|
| MITO-AO | Experimental | Healthy older adult subjects ages 65-75 will take the supplement MITO-AO during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (31P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. Receives: Dietary Supplement: MITO-AO; Other: Passive Leg Movement (PLM); Other: Plantar flexion; Other: Isometric knee extensor test; Other: Bed rest |
| PB-125 | Experimental | Healthy older adult subjects ages 65-75 will take the supplement PB-125 during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. Receives: Dietary Supplement: PB-125; Other: Passive Leg Movement (PLM); Other: Plantar flexion; Other: Isometric knee extensor test; Other: Bed rest |
| Placebo | Placebo comparator | Healthy older adult subjects ages 65-75 will take placebo during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. Receives: Other: Placebo; Other: Passive Leg Movement (PLM); Other: Plantar flexion; Other: Isometric knee extensor test; Other: Bed rest |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in blood vessel diameter after PLM
Measured: 10 days
Change in blood vessel flow rate after PLM
Measured: 10 days
Secondary outcomes (6)
Change in O2 augmented maximal mitochondrial oxidative capacity (Vmax) after plantar flexion
Measured: 10 days
Change in phosphocreatinine concentration [PCr] after plantar flexion
Measured: 10 days
Change in inorganic phosphate concentration [Pi] after plantar flexion
Measured: 10 days
Change in adenosine triphosphate (ATP) concentration after plantar flexion
Measured: 10 days
Change in muscle mass as measured in kilograms by dual-energy X-ray absorptiometry (DXA) after bed rest.
Measured: 10 days
Change in muscle strength as measured in kilograms after isometric knee extensor testing
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Sep 2019
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized double blind parallel 3 group study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joel Trinity
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor-investigator, Joel Trinity, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04351113
- Sponsor's protocol ID
- IRB_00111321
- Other IDs
- 1R01HL142603-01A1
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2020
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Oxidative Stress to Prevent Vascular and Skeletal Muscle Dysfunction During Disuse
- ClinicalTrials.gov ID
- NCT04351113
- Acronym / sponsor ID
- IRB_00111321
- Conditions
- Aging, Oxidative Stress, Vascular Endothelium, Skeletal Muscle, Antioxidants
- Keywords
- Aging, cardiovascular degeneration, Muscular atrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Joel TrinityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prolonged periods of reduced activity are associated with decreased vascular function and muscle atrophy. Physical inactivity due to acute hospitalization is also associated with impaired recovery, hospital readmission, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle mitochondrial dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are a consequence of the aging process. The combination of inactivity and aging poses an added health threat to these individuals by accelerating the negative impact on vascular and skeletal muscle function and dysfunction. The underlying factors leading to vascular and skeletal muscle dysfunction are unknown, but have been linked to increases in oxidative stress. Additionally, there is a lack of understanding of how vascular function is impacted by inactivity in humans and how these changes are related to skeletal muscle function. It is our goal to investigate the mechanisms that contribute to disuse muscle atrophy and vascular dysfunction in order to diminish their negative impact, and preserve vascular and skeletal muscle function across all the lifespan.
Detailed description
Disuse following injury or during acute hospitalization is associated with a host of negative outcomes including functional deficiencies, hospital readmission, disability, and increased mortality. Older adults are a particularly vulnerable population as functional (vascular and skeletal muscle dysfunction) and structural deficits (loss in muscle mass leading to a reduction in strength) are present as a consequence of the aging process. Any additional and accelerated insult caused by disuse poses a serious health threat to these older individuals by depleting their already diminished physiological and functional reserve and hastening the onset of disability. Current strategies aimed at preserving function during disuse have focused on preserving skeletal muscle mass and strength while the critical role of the vasculature has been largely ignored. Moreover, the underlying cause of dysfunction has not been adequately addressed in humans. This disintegrated and myopic approach likely contributes to the fact that interventions capable of preserving health during disuse do not exist. The vascular and skeletal muscle systems are inextricably linked to optimal mobility through oxygen and nutrient delivery, thus, vascular dysfunction likely contributes to and exacerbates skeletal muscle deficiencies that occur during disuse. To fully understand the impact of disuse on health and mobility and develop effective countermeasures it is our contention that both the vascular and musculoskeletal systems must be examined and the root cause of the problem must be addressed. While the underlying factors leading to these accelerated losses during disuse are unknown, they appear to be mechanistically linked to oxidative stress.
The long term goal is to minimize losses in vascular and skeletal muscle function that occur during disuse in order to maintain functional reserve and avoid serious adverse events. The objective here, which is the next step in pursuit of this goal, is to determine how oxidative stress contributes to disuse-induced vascular and skeletal muscle dysfunction. It is our central hypothesis that oxidative stress triggers the accelerated declines in vascular and skeletal muscle function during disuse. To test this hypothesis and provide compelling evidence that oxidative stress is the trigger of dysfunction the investigators will utilize two novel and fundamentally distinct strategies to improve redox balance during disuse. In Aim 1, the mitochondrial targeted antioxidant (MITO-AO) mitoquinone will be administered during disuse to improve free radical scavenging at the level of the mitochondria. In Aim 2, activation of Nuclear Factor Erythroid-2-like 2 (Nrf2) the "master regulator of antioxidant enzymes" will be accomplished with PB125 (a novel naturally occurring Nrf2 activator) to augment endogenous antioxidant defense systems. The impact of these interventions on measures of isolated and integrated vascular and skeletal muscle function before and after disuse will be examined. The central hypothesis is supported by preliminary data reporting substantial losses in vascular and skeletal muscle function and concomitant increases in oxidative stress following 5 days of bed rest. Importantly, MITO-AO prevents disuse-induced losses in muscle mass and restores age-related deficits in vascular function in aged animals and humans (preliminary data). Additionally, PB125 activates the Nrf2 pathway at multiple control points resulting in prolonged and amplified activation and subsequent gene expression of key antioxidant enzymes leading to a decrease in oxidative stress in humans (preliminary data).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized double blind parallel 3 group study
| Arm | Type | Receives |
|---|---|---|
| MITO-AO | Experimental | Dietary Supplement: MITO-AO, Other: Passive Leg Movement (PLM), Other: Plantar flexion, Other: Isometric knee extensor test, Other: Bed restHealthy older adult subjects ages 65-75 will take the supplement MITO-AO during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (31P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. |
| PB-125 | Experimental | Dietary Supplement: PB-125, Other: Passive Leg Movement (PLM), Other: Plantar flexion, Other: Isometric knee extensor test, Other: Bed restHealthy older adult subjects ages 65-75 will take the supplement PB-125 during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. |
| Placebo | Placebo comparator | Other: Placebo, Other: Passive Leg Movement (PLM), Other: Plantar flexion, Other: Isometric knee extensor test, Other: Bed restHealthy older adult subjects ages 65-75 will take placebo during a 5 day bed rest and will be assessed for vascular function independent of metabolism with passive leg movement (PLM), skeletal muscle bioenergetics independent of vascular constraints (i.e. blood flow and O2 supply) with phosphorous magnetic resonance spectroscopy (P-MRS), and skeletal muscle bioenergetics under normal blood flow and O2 supply. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age between 65-85 yrs
- Ability to sign informed consent
- Montreal cognitive assessment (MOCA) exam score greater-than or equal to 26 4. Free-living, prior to admission
Key exclusion criteria (27 listed)
- Cardiac abnormalities considered exclusionary by the study physician (e.g., congestive heart failure (CHF), coronary artery disease (CAD), right-to-left shunt)
- Uncontrolled endocrine or metabolic disease (e.g., hypo/hyperthyroidism, diabetes)
- Glomerular filtration rate (GFR) less-than 30 mL/min/1.73m2 or evidence of kidney disease or failure
- Vascular disease or risk factors of peripheral atherosclerosis. (e.g., uncontrolled hypertension, obesity, diabetes, hypercholesterolemia greater-than 250 mg/dl, claudication or evidence of venous or arterial insufficiency upon palpitation of femoral, popliteal and pedal arteries)
- Risk of deep vein thrombosis (DVT) including family history of thrombophilia, DVT, pulmonary emboli, myeloproliferative diseases including polycythemia (Hb greater-than 18 g/dL) or thrombocytosis (platelets greater-than 400x103/mL), and connective tissue diseases (positive lupus anticoagulant), hyperhomocysteinemia, deficiencies of factor V Leiden, proteins S and C, and antithrombin III
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MITO-AOParticipants will receive 160 mg with breakfast on day 1 of bed rest and 40 mg with breakfast on days 2-5. | Dietary supplement | MITO-AO |
| PB-125Participants will receive 100 mg on days 1-5 of bed rest. | Dietary supplement | PB-125 |
| PlaceboParticipants will receive Placebo on days 1-5 of bed rest. | Other | Placebo |
| Passive Leg Movement (PLM)Participants will be tested for passive leg movement on baseline day 1, bed rest day 1, and post bed rest. | Other | MITO-AO, PB-125, Placebo |
| Plantar flexionParticipants will undergo plantar flexion on baseline day 2, pre bed rest, and post bed rest. | Other | MITO-AO, PB-125, Placebo |
| Isometric knee extensor testParticipants will undergo isometric knee extension on baseline day 2, pre bed rest, and post bed rest. | Other | MITO-AO, PB-125, Placebo |
| Bed restParticipants will undergo 5 days bed rest after 5 day baseline assessments | Other | MITO-AO, PB-125, Placebo |
Primary outcome
Change in blood vessel diameter after PLM
Time frame: 10 days
Change in blood vessel flow rate after PLM
Time frame: 10 days
6 secondary outcomes
Change in O2 augmented maximal mitochondrial oxidative capacity (Vmax) after plantar flexion
Time frame: 10 days
Change in phosphocreatinine concentration [PCr] after plantar flexion
Time frame: 10 days
Change in inorganic phosphate concentration [Pi] after plantar flexion
Time frame: 10 days
Change in adenosine triphosphate (ATP) concentration after plantar flexion
Time frame: 10 days
Change in muscle mass as measured in kilograms by dual-energy X-ray absorptiometry (DXA) after bed rest.
Time frame: 10 days
Change in muscle strength as measured in kilograms after isometric knee extensor testing
Time frame: 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MITO-AO, PB-125 and Passive Leg Movement (PLM) in people with Aging and Oxidative Stress, run by Joel Trinity at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood vessel diameter after PLM (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.