Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03981640
Other study ID # 1614
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date September 2025

Study information

Verified date April 2024
Source University of Massachusetts, Boston
Contact Rachel C Drew, PhD
Phone (617) 287-4061
Email rachel.drew@umb.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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). 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 to test the hypotheses that the renal vasoconstrictor response to acute dynamic exercise, as well as a cold pressor and mental stress tests, is exaggerated in healthy young AA compared to W adults. To test these hypotheses, the investigators will measure RBF and blood pressure at rest and during cycling exercise and a cold pressor and mental stress tests to calculate renal vascular resistance responses to these acute interventions. 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 32
Est. completion date September 2025
Est. primary completion date September 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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) - Smoker/Tobacco user - Acute medical conditions - Taking prescribed medications with exception of birth control pills

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Acute exercise
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 test
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 test
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.

Locations

Country Name City State
United States University of Massachusetts Boston Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
University of Massachusetts, Boston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Rating of perceived exertion during acute exercise For the acute exercise intervention, the rating will be taken during the last 30 seconds of steady-state exercise. The Borg Scale of Perceived Exertion will be used, with which a rating from 6 to 20 will be taken, with 6 representing no exertion and 20 representing maximal exertion. During last 30 seconds of steady-state exercise
Other Rating of hand pain during cold pressor test For the cold pressor test intervention, the rating will be taken during the last 30 seconds of the cold pressor test. A scale from 0 to 10 will be used to take the rating, with 0 representing no pain and 10 representing the worst possible pain. During last 30 seconds of cold pressor test
Other Rating of cold perception during cold pressor test For the cold pressor test intervention, the rating will be taken during the last 30 seconds of the cold pressor test. A scale from 0 to -11 will be used to take the rating, with 0 representing no perceived cold and -11 representing unbearable cold. During last 30 seconds of cold pressor test
Other Rating of perceived stress during mental stress test For the mental stress test intervention, the rating will be taken during the last 30 seconds of the mental stress test. A scale from 0 to 4 will be used to take the rating, with 0 representing no perceived stress and 4 representing extremely stressful. During last 30 seconds of mental stress test
Primary 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. Pre-acute exercise and during steady-state exercise
Primary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Primary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-acute exercise and during steady-state exercise
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
Secondary 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. Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test
See also
  Status Clinical Trial Phase
Completed NCT05034380 - Epigenetic Effects of a Single Bout of Exercise on Cardiovascular Risk Factors and the Metabolome N/A
Recruiting NCT05588674 - The Effect of Probiotics on Exercise Performance and Recovery N/A
Completed NCT05298202 - The Influence of Capsaicin Gel During Exercise Within the Heat Phase 4
Completed NCT05302804 - The Influence of Menthol Gel During Exercise With Heat Phase 4
Recruiting NCT06217068 - Comparative Analysis of Biomarkers in Response to Acute Moderate-Intensity Activity Phase 1/Phase 2
Completed NCT03143868 - Role of Acute Exercise Modality on Appetite Regulation and Energy Intake N/A
Completed NCT05586451 - Muscle Activation With Acute Bouts of Blood Flow Restricted Resistance Exercise N/A
Recruiting NCT05389033 - Probiotic Supplementation and Exercise Performance in the Heat N/A
Completed NCT05170464 - The Acute Effects of Exercise and Caffeine on Working Memory During Acute Caffeine Deprivation Phase 2/Phase 3
Completed NCT05369715 - Diurnal Variation of Exercise on Metabolic Health N/A
Completed NCT05214027 - The Effect of an Acute Bout of Exercise on Serum Vitamin D Concentration