MedDataX Logo

Evaluating the Relationship Between Stress, Ethnicity, and Blood Pressure

NCT ID: NCT00783497

Last Updated: 2015-12-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

203 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-10-31

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

High Blood Pressure Stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Caucasian Americans

No interventions assigned to this group

2

African Americans

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joel E. Dimsdale, M.D.

Emeritus Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joel E. Dimsdale, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of California, San Diego

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R01HL036005

Identifier Type: NIH

Identifier Source: secondary_id

View Link

5R01HL036005-23

Identifier Type: NIH

Identifier Source: secondary_id

View Link

599

Identifier Type: -

Identifier Source: org_study_id