"Neighborhood Disadvantage, Sleep and Vascular Health" (NDSVH)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04576338|
Recruitment Status : Enrolling by invitation
First Posted : October 6, 2020
Last Update Posted : January 19, 2021
|Condition or disease|
|Blood Pressure Sleep Racism Stiffness, Arterial Endothelial Dysfunction|
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||"Neighborhood Disadvantage, Sleep, and Vascular Health: Racial Disparities in Cardiometabolic Health and Blood Pressure"|
|Actual Study Start Date :||January 11, 2020|
|Estimated Primary Completion Date :||December 1, 2022|
|Estimated Study Completion Date :||May 31, 2023|
The cohort consists of Black and White college students at a university in a southeastern state in America.
- Flow-mediated dilation (FMD) [ Time Frame: Baseline racial comparison ]Flow-mediated vasodilation will be assessed using continuous measures of brachial artery diameter and velocity via duplex Doppler ultrasound (Hitachi Arietta 70). The brachial artery will be imaged in the longitudinal plane proximal to the medial epicondyle using a high-frequency (6-12 MHz) linear-array probe. The ultrasound probe will be stabilized using a custom-built clamp. Shear rate (sec-1) will be calculated as [(blood flow velocity (cm*s-1) *4)/blood vessel diameter (mm)] The image will be recorded throughout a 60-s baseline, a 300-s ischemic stimulus (250 mmHg), and 180 seconds post deflation. FMD will be expressed as % dilation (final diameter-baseline diameter/baseline diameter x 100) and also normalized to the shear stimulus. Allometric scaling will be used if appropriate, including if there are baseline differences in artery diameter by race or condition.
- Pulse wave velocity (arterial stiffness) [ Time Frame: Baseline racial comparison ]The investigators will use the SphygmoCor XCEL system to assess pulse wave velocity (PWV). A high-fidelity strain-gauge transducer is used to obtain the pressure waveform at the carotid pulse. Distances from the carotid artery sampling site to the femoral artery (upper leg instrumented with a thigh cuff for oscillometric sphygmomanometry), and from the carotid artery to the suprasternal notch will be recorded.PWV will be expressed as cm/s.
- Pulse wave analysis (arterial stiffness) [ Time Frame: Baseline racial comparison ]The investigators will use the SphygmoCor XCEL system to assess pulse wave analysis (PWA) using an upper arm blood pressure cuff. PWA will be expressed as % (calculated as augmentation pressure divided by the pulse pressure).
- 24-hour ambulatory blood pressure [ Time Frame: Baseline racial comparison ]Participants will wear an Oscar2 (with SphygmoCor) ambulatory blood pressure monitor on their upper arm for up to 24-hours preceding their study visit to measure systolic and diastolic blood pressure. The purpose of the ambulatory blood pressure monitoring is to determine blood pressure regulation over an entire day. This blood pressure monitor will be set to automatically take blood pressure every 20 minutes. The monitor records and saves each blood pressure measurement automatically.
- Blood pressure reactivity [ Time Frame: Baseline racial comparison ]The investigators will measure systolic and diastolic pressure using photoplethysmography at the finger. Systolic and diastolic blood pressure will be assessed at rest and during handgrip exercise. Blood pressure reactivity will be expressed as a change in pressure (mmHg) from baseline to a predetermined time during the stressor (e.g., minute one average and minute two average).
- Objective sleep duration and quality [ Time Frame: Baseline racial comparison ]Philips actiwatch spectrum will be used to quantify sleep duration. Participants will wear the watch units for 7 days. The investigators will cross-check actigraphy wear times with a sleep diary.
- Subjective sleep quality [ Time Frame: Baseline racial comparison ]The investigators will use the Pittsburgh Sleep Quality Index (PSQI) to asses sleep duration and perceived sleep quality reflective of the one month period leading into the study. The PSQI global score has a possible range of 0-21 points.
- Circulating reactive oxygen species [ Time Frame: Baseline racial comparison ]The investigators will use electron paramagnetic resonance to measure reactive oxygen species (spectra units) in whole blood samples treated with a spin probe.
- Blood biomarkers of nitric oxide bioavailability [ Time Frame: Baseline racial comparison ]The investigators will measure nitric oxide metabolites (nitrate and nitrite nanomolar concentration) using chemiluminescence
- Physical activity [ Time Frame: Baseline racial comparison ]Participants will wear an ActiGraph GT3X accelerometer for seven days to objectively quantify steps per day and metabolic equivalents per day.
- Mental health - social anxiety [ Time Frame: Baseline racial comparison ]The investigators will administer the Liebowitz Social Anxiety Scale. The scale starts at 0 (none) and ends at 3 (severe) for 24 questions related to anxiety and avoidance, and a cumulative score is calculated.
- Mental health - depression [ Time Frame: Baseline racial comparison ]The investigators will administer the Beck's Depression Inventory. The scale starts at 0 and ends at 3 for 21 questions related to depression.
- Neighborhood disadvantage [ Time Frame: Baseline racial comparison ]The investigators will ask participants to identify their home addresses with investigator assistance and Google maps and potential assistance from their guardians or parents during early- and mid-childhood and adolescence. The investigators will use the participant's address and census tract information to determine measures of neighborhood quality such as median income, crime rates, and median education level.
- Habitual dietary intake [ Time Frame: Baseline racial comparison ]The investigators will instruct participants to complete a diet log for 5 days which will be operationalized with Nutrition Data System for Research (NDSR).
- 24-hour urine electrolytes [ Time Frame: Baseline racial comparison ]The investigators will use an electrolyte analyzer to assess sodium, potassium, and chloride concentration. The investigators will use urine volume and electrolyte concentration to determine 24-hour electrolyte excretion
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04576338
|United States, Alabama|
|Auburn, Alabama, United States, 36949|