NCT04576338

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

October 6, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

2.2 years

First QC Date

September 19, 2020

Last Update Submit

August 12, 2024

Conditions

Keywords

blood pressuresleependothelial dysfunctionsocial determinants of healtharterial stiffness

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

Age19 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

Location

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.

  • Robinson 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.

  • Culver 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.

  • 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 Ambulatory Blood Pressure in Young Adults. medRxiv [Preprint]. 2023 Sep 12:2023.09.11.23295160. doi: 10.1101/2023.09.11.23295160.

Biospecimen

Retention: SAMPLES WITHOUT DNA

The investigators will store plasma, serum, and urine samples

MeSH Terms

Conditions

Racism

Condition Hierarchy (Ancestors)

PrejudiceSocial BehaviorBehaviorSocial Discrimination

Study Officials

  • Austin T Robinson, PhD

    Auburn University

    PRINCIPAL INVESTIGATOR

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

Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate DMDA approvals

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.

Locations