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Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

Central and Peripheral Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03934255
Enrollment
32
Registered
2019-05-01
Start date
2020-01-01
Completion date
2023-05-01
Last updated
2023-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure, Circadian Rhythm

Brief summary

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

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.

Interventions

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

Sponsors

American Heart Association
CollaboratorOTHER
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Core body temperature phaseCore body temperature phase during a 30-hour constant routine protocolCircadian phase of core body temperature recorded and transmitted wirelessly
Core body temperature amplitudeCore body temperature amplitude during a 30-hour constant routine protocolCircadian amplitude of core body temperature recorded and transmitted wirelessly
Buccal cell mRNA expressionExpression of Bmal1 and Period 3 during a 30-hour constant routine protocolExpression of Bmal1 and Period 3 obtained from buccal cell mRNA
Melatonin amplitudeMelatonin amplitude during a 30-hour constant routine protocolCircadian amplitude of melatonin obtained from saliva
Melatonin phaseMelatonin phase during a 30-hour constant routine protocolCircadian phase of melatonin obtained from saliva

Secondary

MeasureTime frameDescription
Cortisol amplitudeCortisol amplitude during a 30-hour constant routine protocolCircadian amplitude of cortisol obtained rom saliva
Cortisol phaseCortisol phase during a 30-hour constant routine protocolCircadian phase of cortisol obtained rom saliva

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026