Circadian RhythmNCT03934255
Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks
A study testing Constant Routine Protocol in people with Circadian Rhythm and Blood Pressure, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Circadian Rhythm, Blood Pressure
- What is being tested?
- Constant Routine Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 1 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Black or African American race
- Age 18 years or older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0017
About this study
Official title: Central and Peripheral Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks
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.
Read the 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.
- Conditions
- Circadian Rhythm, Blood Pressure
- Being tested
- Constant Routine Protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Constant Routine ProtocolOther
Constant routine protocols are used in circadian research to examine underlying circadian rhythms in the absence of light, activity, and meals
| Study group | Role | What they receive |
|---|---|---|
| Constant Routine Protocol | Experimental | Participants will be kept in constant conditions for 30 hours to observe circadian physiology in the absence of light, physical activity, and meals. Receives: Other: Constant Routine Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Melatonin phase
Circadian phase of melatonin obtained from saliva
Measured: Melatonin phase during a 30-hour constant routine protocol
Melatonin amplitude
Circadian amplitude of melatonin obtained from saliva
Measured: Melatonin amplitude during a 30-hour constant routine protocol
Core body temperature phase
Circadian phase of core body temperature recorded and transmitted wirelessly
Measured: Core body temperature phase during a 30-hour constant routine protocol
Core body temperature amplitude
Circadian amplitude of core body temperature recorded and transmitted wirelessly
Measured: Core body temperature amplitude during a 30-hour constant routine protocol
Buccal cell mRNA expression
Expression of Bmal1 and Period 3 obtained from buccal cell mRNA
Measured: Expression of Bmal1 and Period 3 during a 30-hour constant routine protocol
Secondary outcomes (2)
Cortisol phase
Circadian phase of cortisol obtained rom saliva
Measured: Cortisol phase during a 30-hour constant routine protocol
Cortisol amplitude
Circadian amplitude of cortisol obtained rom saliva
Measured: Cortisol amplitude during a 30-hour constant routine protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2019
- Study start1 Jan 2020
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Circadian RhythmStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Constant routine protocol in Blacks with dipping and non-dipping blood pressure
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Stephen Justin Thomas, PhD, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03934255
- Sponsor's protocol ID
- IRB-300003266
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2019
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Details regarding sharing IPD are undecided. Protocols and consent forms will be shared. Requests may be made to the study PI.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Circadian Mechanisms Underlying Non-Dipping Blood Pressure in Blacks
- ClinicalTrials.gov ID
- NCT03934255
- Acronym / sponsor ID
- IRB-300003266
- Conditions
- Circadian Rhythm, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 1 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Constant routine protocol in Blacks with dipping and non-dipping blood pressure
| Arm | Type | Receives |
|---|---|---|
| Constant Routine Protocol | Experimental | Other: Constant Routine ProtocolParticipants will be kept in constant conditions for 30 hours to observe circadian physiology in the absence of light, physical activity, and meals. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Black or African American race
- Age 18 years or older
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Constant Routine ProtocolConstant routine protocols are used in circadian research to examine underlying circadian rhythms in the absence of light, activity, and meals | Other | Constant Routine Protocol |
Primary outcome
Melatonin phase
Time frame: Melatonin phase during a 30-hour constant routine protocol
Circadian phase of melatonin obtained from saliva
Melatonin amplitude
Time frame: Melatonin amplitude during a 30-hour constant routine protocol
Circadian amplitude of melatonin obtained from saliva
Core body temperature phase
Time frame: Core body temperature phase during a 30-hour constant routine protocol
Circadian phase of core body temperature recorded and transmitted wirelessly
Core body temperature amplitude
Time frame: Core body temperature amplitude during a 30-hour constant routine protocol
Circadian amplitude of core body temperature recorded and transmitted wirelessly
Buccal cell mRNA expression
Time frame: Expression of Bmal1 and Period 3 during a 30-hour constant routine protocol
Expression of Bmal1 and Period 3 obtained from buccal cell mRNA
2 secondary outcomes
Cortisol phase
Time frame: Cortisol phase during a 30-hour constant routine protocol
Cortisol amplitude
Time frame: Cortisol amplitude during a 30-hour constant routine protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- Individual participant dataSharing planned: Undecided. Details regarding sharing IPD are undecided. Protocols and consent forms will be shared. Requests may be made to the study PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Constant Routine Protocol in people with Circadian Rhythm and Blood Pressure, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin phase (time frame: Melatonin phase during a 30-hour constant routine protocol). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2023.