Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

NCT ID: NCT03934255

Last Updated: 2023-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2023-05-01

Brief Summary

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This study seeks to examine central and peripheral circadian mechanisms in Blacks with appropriately dipping systolic blood pressure (blood pressure that dips by at least 10%) compared with non-dipping systolic blood pressure (blood pressure that dips by less than 10%) using a constant routine protocol. Constant routine protocols are commonly used in the field of circadian biology to examine rhythms in biological processes while controlling the entraining effects of light, activity, and diet.

Detailed Description

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This study will enroll a total of 40 participants (n=20 non-dippers; n=20 dippers) to complete a 30-hour constant routine protocol. Participants will undergo baseline testing that includes anthropometric measurements, clinic blood pressure measurements, completion of self-report questionnaires on sleep and mood, be fitted with an ambulatory blood pressure monitor and actigraphy watch, and be provided with home sleep testing (HST) equipment.

Following completion of baseline assessment, eligible participants will be scheduled for the 30-hour constant routine protocol. The 30-hour constant routine protocol will allow for the hourly collection of saliva, collection of buccal cells every 4 hours, and constant monitoring of core body temperature, all of which are primary outcomes in the assessment of central and peripheral circadian clock markers. Amplitude and phase of these outcomes will be assessed in non-dippers versus dippers.

Conditions

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Circadian Rhythm Blood Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Constant routine protocol in Blacks with dipping and non-dipping blood pressure
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Constant Routine Protocol

Participants will be kept in constant conditions for 30 hours to observe circadian physiology in the absence of light, physical activity, and meals.

Group Type EXPERIMENTAL

Constant Routine Protocol

Intervention Type OTHER

Constant routine protocols are used in circadian research to examine underlying circadian rhythms in the absence of light, activity, and meals

Interventions

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Constant Routine Protocol

Constant routine protocols are used in circadian research to examine underlying circadian rhythms in the absence of light, activity, and meals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Black or African American race
* Age 18 years or older

Exclusion Criteria

* Work alternating or night shifts
* Pregnant or nursing
* Current illicit drug use
* History of severe mental illness
* Medical conditions that would be contraindicated for a constant routine protocol
* Take anti-hypertensive medications or beta-blockers
* Severe obstructive sleep apnea
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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Stephen Justin Thomas, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Countries

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United States

Other Identifiers

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IRB-300003266

Identifier Type: -

Identifier Source: org_study_id

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