"Neighborhood Disadvantage, Sleep and Vascular Health"
NDSVH
1 other identifier
observational
55
1 country
1
Brief Summary
The purpose of the study is to find out the effects of neighborhood disadvantage and sleep disparities contribute to racial disparities in cardiometabolic health and blood pressure in young adults.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2020
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2020
CompletedFirst Submitted
Initial submission to the registry
September 19, 2020
CompletedFirst Posted
Study publicly available on registry
October 6, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedAugust 13, 2024
August 1, 2024
2.2 years
September 19, 2020
August 12, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Flow-mediated dilation (FMD)
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.
Baseline racial comparison
Pulse wave velocity (arterial stiffness)
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.
Baseline racial comparison
Pulse wave analysis (arterial stiffness)
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).
Baseline racial comparison
24-hour ambulatory blood pressure
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.
Baseline racial comparison
Blood pressure reactivity
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).
Baseline racial comparison
Objective sleep duration and quality
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.
Baseline racial comparison
Subjective sleep quality
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.
Baseline racial comparison
Secondary Outcomes (7)
Circulating reactive oxygen species
Baseline racial comparison
Blood biomarkers of nitric oxide bioavailability
Baseline racial comparison
Physical activity
Baseline racial comparison
Mental health - social anxiety
Baseline racial comparison
Mental health - depression
Baseline racial comparison
- +2 more secondary outcomes
Other Outcomes (1)
24-hour urine electrolytes
Baseline racial comparison
Study Arms (1)
College Students
The cohort consists of Black and White college students at a university in a southeastern state in America.
Eligibility Criteria
The cohort consists of Black and White college students at a university in a southeastern state in America. The cohort will be, by design, generally healthy, young adults free from known cardiometabolic disease,
You may not qualify if:
- Systolic blood pressure greater than 150 mmHg
- Diastolic blood pressure greater than 90 mmHg
- Body mass index above 35 kg/m\^2
- History of cardiovascular disease
- Recent (one year) history of cancer
- History of metabolic disease (e.g. type 2 diabetes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kinesiology Building
Auburn, Alabama, 36949, United States
Related Publications (4)
Jeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of race and neighborhood deprivation on resting and ambulatory blood pressure in young adults. Am J Physiol Heart Circ Physiol. 2024 Sep 1;327(3):H601-H613. doi: 10.1152/ajpheart.00726.2023. Epub 2024 Jul 12.
PMID: 38995211RESULTRobinson AT, Linder BA, Barnett AM, Jeong S, Sanchez SO, Nichols OI, McIntosh MC, Hutchison ZJ, Tharpe MA, Watso JC, Gutierrez OM, Fuller-Rowell TE. Cross-sectional analysis of racial differences in hydration and neighborhood deprivation in young adults. Am J Clin Nutr. 2023 Oct;118(4):822-833. doi: 10.1016/j.ajcnut.2023.08.005. Epub 2023 Aug 22.
PMID: 37619651RESULTCulver MN, Linder BA, Lyons DE, Hutchison ZJ, Garrett CL, McNeil JN, Robinson AT. Do not sleep on vitamin D: vitamin D is associated with sleep variability in apparently healthy adults. Am J Physiol Regul Integr Comp Physiol. 2025 Mar 1;328(3):R262-R273. doi: 10.1152/ajpregu.00168.2024. Epub 2025 Jan 28.
PMID: 39873709DERIVEDJeong S, Linder BA, Barnett AM, Tharpe MA, Hutchison ZJ, Culver MN, Sanchez SO, Nichols OI, Grosicki GJ, Bunsawat K, Nasci VL, Gohar EY, Fuller-Rowell TE, Robinson AT. Interplay of Race and Neighborhood Deprivation on Ambulatory Blood Pressure in Young Adults. medRxiv [Preprint]. 2023 Sep 12:2023.09.11.23295160. doi: 10.1101/2023.09.11.23295160.
PMID: 37745604DERIVED
Biospecimen
The investigators will store plasma, serum, and urine samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin T Robinson, PhD
Auburn University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
September 19, 2020
First Posted
October 6, 2020
Study Start
January 11, 2020
Primary Completion
April 1, 2022
Study Completion
December 31, 2023
Last Updated
August 13, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Following study completion, indefinitely
- Access Criteria
- Upon reasonable request such as request to collaborate, performing a meta-analysis, or determine reliability, data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals.
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals