HypertensionNCT00783497
Evaluating the Relationship Between Stress, Ethnicity, and Blood Pressure
An observational study of Hypertension, run by University of California, San Diego at 1 site in United States.
Trial summary
High blood pressure is a common health problem among people in the United States. This study will examine the ways that stress and ethnicity play a role in the development of high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- How many people
- 203 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Dec 2010
- Phase
- Observational
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community sample in the San Diego, California metropolitan area
Who may be able to join
- Self-identifies as African American or Caucasian
- Weighs 85% to 150% of ideal weight (approximate BMI of 17.5 to 30)
- In good physical health
Who cannot join
- Blood pressure greater than 180/110 mm Hg at any point in the past
- Currently works less than half-time
- Currently is employed doing shift work
- Currently takes prescription medication, other than anti-hypertensive medication
- Currently smokes
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego
San Diego, California, 92103
About this study
Official title: Stress, Blood Pressure, & Ethnicity
High blood pressure is a common health problem among people in the United States. This study will examine the ways that stress and ethnicity play a role in the development of high blood pressure.
Read the detailed description
High blood pressure affects nearly one third of all people in the United States. It can be caused by many factors, including obesity, sodium intake, genetics, and stress. Ethnicity appears to also play a role, because African Americans are more susceptible to developing high blood pressure than other ethnic groups, with more than 40% of African Americans diagnosed with this condition. This study will examine the underlying reasons of why stress and African-American ethnicity contribute to high blood pressure risk and how ethnicity and stress interact with each other to increase this risk. Specifically, study researchers will examine how stress increases blood pressure, how people from different ethnic groups respond to stress differently, and how sleep plays a role in regulating blood pressure levels.
This study will enroll African Americans and Caucasians who have high blood pressure, as well as African Americans and Caucasians who have normal blood pressure. Potential participants will go through a screening process that involves a medical history review, questionnaires, and blood pressure monitoring. Eligible participants will then be admitted to the research clinic for a 2-night stay. Participants' nutrition history and body measurements will be obtained, and a catheter will be inserted into the arm so that blood can be easily collected during the clinic stay. During the night, participants' breathing habits and movements will be monitored while they sleep. During the day, blood pressure and heart activity will be monitored frequently, including when participants are asked to perform mildly stressful tasks, such as giving a short speech. Various medications that affect heart rate and blood pressure will be given at different times during the study, and researchers will monitor participants' reactions to each medication. Lastly, participants will also complete psychological questionnaires.
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Stress
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Caucasian Americans | |
| 2 | African Americans |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startOct 2005
- Primary completionSep 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Joel E. Dimsdale, M.D., University of California, San Diego
- Investigators
- Joel E. Dimsdale, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00783497
- Sponsor's protocol ID
- 599
- Other IDs
- R01HL036005, 5R01HL036005-23
- Status last verified
- Dec 2015
- First submitted
- 30 Oct 2008
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress, Blood Pressure, & Ethnicity
- ClinicalTrials.gov ID
- NCT00783497
- Acronym / sponsor ID
- 599
- Conditions
- Hypertension
- Keywords
- High Blood Pressure, Stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Oct 2005
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Oct 2008 (estimated)
- 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.
High blood pressure is a common health problem among people in the United States. This study will examine the ways that stress and ethnicity play a role in the development of high blood pressure.
Detailed description
High blood pressure affects nearly one third of all people in the United States. It can be caused by many factors, including obesity, sodium intake, genetics, and stress. Ethnicity appears to also play a role, because African Americans are more susceptible to developing high blood pressure than other ethnic groups, with more than 40% of African Americans diagnosed with this condition. This study will examine the underlying reasons of why stress and African-American ethnicity contribute to high blood pressure risk and how ethnicity and stress interact with each other to increase this risk. Specifically, study researchers will examine how stress increases blood pressure, how people from different ethnic groups respond to stress differently, and how sleep plays a role in regulating blood pressure levels.
This study will enroll African Americans and Caucasians who have high blood pressure, as well as African Americans and Caucasians who have normal blood pressure. Potential participants will go through a screening process that involves a medical history review, questionnaires, and blood pressure monitoring. Eligible participants will then be admitted to the research clinic for a 2-night stay. Participants' nutrition history and body measurements will be obtained, and a catheter will be inserted into the arm so that blood can be easily collected during the clinic stay. During the night, participants' breathing habits and movements will be monitored while they sleep. During the day, blood pressure and heart activity will be monitored frequently, including when participants are asked to perform mildly stressful tasks, such as giving a short speech. Various medications that affect heart rate and blood pressure will be given at different times during the study, and researchers will monitor participants' reactions to each medication. Lastly, participants will also complete psychological questionnaires.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Caucasian Americans |
| 2 | – | –African Americans |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community sample in the San Diego, California metropolitan area
Key inclusion criteria (3 listed)
- Self-identifies as African American or Caucasian
- Weighs 85% to 150% of ideal weight (approximate BMI of 17.5 to 30)
- In good physical health
Key exclusion criteria (5 listed)
- Blood pressure greater than 180/110 mm Hg at any point in the past
- Currently works less than half-time
- Currently is employed doing shift work
- Currently takes prescription medication, other than anti-hypertensive medication
- Currently smokes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 17 Dec 2015.
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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.
Joel E. Dimsdale, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by University of California, San Diego 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 3 inclusion and 5 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 17 Dec 2015. 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.
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 17 Dec 2015.