Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03934255
• Other study ID #: IRB-300003266
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: May 1, 2023

Study information

• Verified date: June 2023
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Circadian Rhythm

Intervention

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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	American Heart Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Melatonin phase	Circadian phase of melatonin obtained from saliva	Melatonin phase during a 30-hour constant routine protocol
Primary	Melatonin amplitude	Circadian amplitude of melatonin obtained from saliva	Melatonin amplitude during a 30-hour constant routine protocol
Primary	Core body temperature phase	Circadian phase of core body temperature recorded and transmitted wirelessly	Core body temperature phase during a 30-hour constant routine protocol
Primary	Core body temperature amplitude	Circadian amplitude of core body temperature recorded and transmitted wirelessly	Core body temperature amplitude during a 30-hour constant routine protocol
Primary	Buccal cell mRNA expression	Expression of Bmal1 and Period 3 obtained from buccal cell mRNA	Expression of Bmal1 and Period 3 during a 30-hour constant routine protocol
Secondary	Cortisol phase	Circadian phase of cortisol obtained rom saliva	Cortisol phase during a 30-hour constant routine protocol
Secondary	Cortisol amplitude	Circadian amplitude of cortisol obtained rom saliva	Cortisol amplitude during a 30-hour constant routine protocol