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HealthyNCT03981640

Neural Control of Kidney Blood Flow During Exercise in African American Adults

A study testing Acute exercise, Cold pressor test and Mental stress test in people with Healthy, run by University of Massachusetts, Boston at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical trials is to learn if healthy young African American (AA) adults have a larger change in their kidney blood flow during exercise compared to White (W) adults. Read more about this study

Who is it for?
Ages 18 to 35 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
Acute exercise, Cold pressor test and Mental stress test
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteUnited States
Study dates
30 Sep 2024to 30 Apr 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 18 to 35 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Self-report as either African American or White racial identity
  • Born in United States
  • Both biological parents identify as same racial identity as participant
  • Recreationally active (participating in physical activity for at least 20 minutes per day, at least three times per week, but not training for competitive events)
  • Fluent in English

Who cannot join

  • Hispanic or Latino
  • Females who are pregnant or lactating
  • Cardiovascular or renal disease
  • Hypertension (blood pressure of more than or equal to 130/80 mmHg)
  • Diabetes
  • Obesity (body mass index of more than or equal to 30 kg/m2)
Show all 9Show fewer
  • Smoker/Tobacco user
  • Acute medical conditions
  • Taking prescribed cardiovascular, antihypertensive, or renal medications

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Massachusetts Boston

    Boston, Massachusetts, 02125

Other trials in United States

About this study

Official title: Neurovascular Control of Renal Blood Flow During Exercise in African American Adults

The goal of this clinical trials is to learn if healthy young African American (AA) adults have a larger change in their kidney blood flow during exercise compared to White (W) adults. The main questions that this study aims to answer are:

  • Do healthy young AA adults have a larger decrease in kidney blood flow during exercise compared to W adults?
  • Do healthy young AA adults have a larger decrease in kidney blood flow during other types of stress compared to W adults?
Read more

During two visits in the research lab, participants will:

  • Perform a fitness test
  • Perform cycling exercise while lying down
  • Undergo a cold hand test
  • Perform a mental math test

Completing this clinical trial will help researchers to understand more about why many AA adults have heart and kidney problems, so future research can study ways to reduce the number of AA adults who have these health issues.

Read the detailed description

African American (AA) adults have a greater prevalence of developing cardiovascular and renal disease (CVRD) than White (W) adults. Elevated sympathetic nervous system activity is associated with increased incidence of CVRD. Physical exertion, such as exercise, acutely increases sympathetic nervous system activity directed towards the kidneys, resulting in renal vasoconstriction and reduced renal blood flow (RBF). Limited research shows that healthy young AA adults exhibit exaggerated sympathetic responsiveness both at rest and during sympathetic activation, which may be a major contributor to the increased risk of CVRD in this population. However, the acute renal vasoconstrictor response to any sympathetic nervous system activation has not been investigated to date in AA adults. During sympathetic nervous system activation such as exercise, sympathetic outflow to the kidneys in AA adults might be exaggerated, contributing to greater renal vasoconstriction and a larger reduction in RBF. Over time, this exaggerated neurovascular response to sympathetic activation could have a negative cumulative effect on the kidneys, which could be a contributing factor to the greater incidence of CVRD in this population.

Therefore, this study aims to examine the renal vasoconstrictor response to sympathetic stressors in healthy AA adults prior to development of CVRD, which will be achieved via two Specific Aims. In Specific Aim 1, the investigators will test the hypothesis that the renal vasoconstrictor response to acute dynamic exercise is exaggerated in healthy young AA compared to W adults. Specifically, the investigators will measure RBF and blood pressure at rest and during cycling exercise to calculate renal vascular resistance responses to exercise, enabling us to test the hypothesis that healthy young AA adults exhibit an exaggerated renal vasoconstrictor response to acute cycling exercise compared to healthy young W adults. In Specific Aim 2, the investigators will test the hypothesis that the renal vasoconstrictor response to non-exercise sympathetic stressors is exaggerated in healthy young AA compared to W adults. Specifically, the investigators will measure RBF and blood pressure at rest and during a cold pressor and mental stress tests to calculate renal vascular resistance responses to these non-exercise sympathetic stressors, enabling us to test the hypothesis that healthy young AA adults exhibit exaggerated renal vasoconstrictor responses to non-exercise sympathetic stressors compared to healthy young W adults.

Using the highly innovative approach of Doppler ultrasound to measure RBF during exercise and non-exercise sympathetic stressors non-invasively and with high temporal resolution will enable us to assess the renal vasoconstrictor response to sympathetic stressors in healthy AA adults prior to development of CVRD, so the underlying integrative physiological responses to sympathetic activation in AA adults can be understood. Findings from this study in this understudied yet clinically significant area will contribute to the ultimate goal of creating and implementing treatment strategies to reduce the risk of developing CVRD in AA adults.

Conditions
Healthy
Being tested
Acute exercise, Cold pressor test, Mental stress test
Keywords
Exercise, Cold stress, Mental stress
Medical subject headings
Motor Activity, Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute exerciseOther

    Participants will lie in a semi-supine position with their feet attached to the pedals of a custom-arranged cycle ergometer. Participants' 40% heart rate reserve will be calculated, giving the target value to achieve during exercise based on appropriate resistance applied on the cycle ergometer, corresponding to a moderate exercise intensity. After a 5-minute resting baseline, participants will perform dynamic cycling exercise at steady state for up to 20 minutes. They will then stop exercising, and there will be a 5-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived exertion will be taken from participants during the last 30 seconds of steady-state cycling exercise.

  • Cold pressor testOther

    Participants will lie in a semi-supine position, and after a 3-minute resting baseline, participants will have their hand immersed in ice water for 2 minutes. This cold pressor test represents the non-exercise, physical sympathetic stressor. Participants' hand will then be removed from the ice water, followed by a 3-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. Ratings of hand pain and cold perception will be taken from participants during the last 30 seconds of the cold pressor test.

  • Mental stress testOther

    Participants will lie in a semi-supine position, and after a 3-minute resting baseline, participants will perform a mental arithmetic task for 5 minutes. This mental stress test represents the non-exercise, psychological sympathetic stressor. Participants will be instructed to subtract a given number from a randomly selected three-digit number and verbally state their answer and continue to do so for the duration of the test. Participants will be instructed to state their answers as quickly and accurately as possible. Participants will then stop the arithmetic task, and a 3-minute recovery period will follow. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived stress will be taken from participants during the last 30 seconds of the mental stress test.

Study groups in NCT03981640
Study groupRoleWhat they receive
African American AdultsExperimentalAfrican American adults will undergo the interventions of acute exercise, a cold pressor test, and a mental stress test while beat-to-beat renal blood flow velocity, mean arterial blood pressure, and heart rate are recorded.
Receives: Other: Acute exercise; Other: Cold pressor test; Other: Mental stress test
White AdultsExperimentalWhite adults will undergo the interventions of acute exercise, a cold pressor test, and a mental stress test while beat-to-beat renal blood flow velocity, mean arterial blood pressure, and heart rate are recorded.
Receives: Other: Acute exercise; Other: Cold pressor test; Other: Mental stress test

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in renal vascular resistance during acute exercise

    For the acute exercise intervention, the percent change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  2. Change in renal vascular resistance during cold pressor test

    For the cold pressor test intervention, the percent change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  3. Change in renal vascular resistance during mental stress test

    For the mental stress test intervention, the percent change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

Secondary outcomes (24)
  1. Change in renal blood flow velocity during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  2. Change in mean arterial blood pressure during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  3. Change in systolic blood pressure during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  4. Change in diastolic blood pressure during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  5. Change in heart rate during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  6. Change in cardiac output during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  7. Change in stroke volume during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  8. Change in total peripheral resistance during acute exercise

    For the acute exercise intervention, the absolute change from pre-acute exercise to during steady-state exercise will be assessed.

    Measured: Pre-acute exercise and during steady-state exercise

  9. Change in renal blood flow velocity during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  10. Change in mean arterial blood pressure during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  11. Change in systolic blood pressure during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  12. Change in diastolic blood pressure during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  13. Change in heart rate during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  14. Change in cardiac output during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  15. Change in stroke volume during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  16. Change in total peripheral resistance during cold pressor test

    For the cold pressor test intervention, the absolute change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Measured: Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  17. Change in renal blood flow velocity during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  18. Change in mean arterial blood pressure during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  19. Change in systolic blood pressure during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  20. Change in diastolic blood pressure during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  21. Change in heart rate during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  22. Change in cardiac output during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  23. Change in stroke volume during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

  24. Change in total peripheral resistance during mental stress test

    For the mental stress test intervention, the absolute change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Measured: Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start30 Sep 2024
  3. Primary completion30 Apr 2026
  4. Study completion30 Apr 2026

Resources

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
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981640
Sponsor's protocol ID
1614
Other IDs
1R15HL152359-01A1
Status last verified
Aug 2026
First submitted
4 Jun 2019
Last updated
25 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Acute exercise, Cold pressor test and Mental stress test in people with Healthy, run by University of Massachusetts, Boston 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 5 inclusion and 9 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 25 Aug 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. 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 renal vascular resistance during acute exercise (time frame: Pre-acute exercise and during steady-state exercise). The study lists 3 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 25 Aug 2026.

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