HypertensionNCT00384241
Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
An observational study of Hypertension, run by Augusta University at 1 site in United States.
Trial summary
High blood pressure affects nearly one third of all individuals in the United States. If left untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Induced Stress and Buccal Swab
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,099 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Jul 2009
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 15-19 years old African American and European American school children.
Who may be able to join
- Participated in two previous NIH funded studies HL073260, HL077230
- Biological parents willing to participate in the study
- African American or European origins
Who cannot join
- Non-biological parents
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Georgia, Georgia Regents University
Augusta, Georgia, 30912
About this study
Official title: Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
High blood pressure affects nearly one third of all individuals in the United States. If left untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness. For many people, the exact cause of high blood pressure is unknown, but it is believed that both genetic and environmental factors contribute to the development of the condition. The purpose of this study is to examine the importance of genetics, inflammation, and stress on the development of high blood pressure.
Read the detailed description
High blood pressure is a complex condition that can be caused by many factors, including obesity, diet, genetics, or stress. Maintaining a healthy balance of sodium in the body is important for adequate blood pressure control. Some individuals experience sustained high blood pressure during periods of extended stress, combined with the inability to excrete enough sodium through urine to re-establish normal blood pressure levels. This type of stress-induced high blood pressure is related to interleukin-6 (IL-6), a protein that stimulates inflammation and immune responses. To determine the interaction between stress, inflammation, and genetics, this study will examine the role of IL-6 in regulating sodium levels and blood pressure in individuals undergoing stress. This information will be useful in determining new ways to evaluate risk factors for high blood pressure.
This study will examine previously collected DNA samples from young adults who participated in prior genetic studies. There will be no study visits for participants. IL-6, IL-6R, glycoprotein 130 (gp130), and C-reactive protein (CRP) genes will be analyzed in all samples; changes in plasma levels of IL-6 and CRP in response to stress will be examined in selected samples. The parents of participants will be asked to provide cheek swabs for additional DNA analysis.
- Conditions
- Hypertension
- Being tested
- Induced Stress, Buccal Swab
- Keywords
- Blood Pressure, High, Stress, Inflammation
- Medical subject headings
- Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Induced StressBehavioural
Participation in an active coping task by playing a video game against another participant.
Buccal SwabProcedure or surgery
One Buccal swab collected from each parent
| Study group | Role | What they receive |
|---|---|---|
| Children | Children age 15-19, self reported as African American of European Origin, healthy non-smoker, with normal blood pressure, exposed to an activity to that results in induced stress Receives: Behavioral: Induced Stress | |
| Parents | Collection of buccal swab Parent of participants in the Children Arm Receives: Procedure: Buccal Swab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urinary Sodium Excretion (UNaV)
The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.
Measured: Baseline and 4 hour
Secondary outcomes (1)
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
Stress induced systolic blood pressure (SBP) data generated from two previous studies was collected. In the previous studies, systolic blood pressures were measured before and after completing a video game challenge. Stress induced SBP is defined as delta SBP = stress SBP - baseline SBP.
Measured: baseline and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2006 (estimated)
- Study startAug 2006
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,099 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Haidong Zhu, MD, PhD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00384241
- Sponsor's protocol ID
- 1359
- Other IDs
- R21HL085817, 1R21HL085817-01
- Status last verified
- May 2015
- First submitted
- 4 Oct 2006
- Last updated
- 3 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
- ClinicalTrials.gov ID
- NCT00384241
- Acronym / sponsor ID
- 1359
- Conditions
- Hypertension
- Keywords
- Blood Pressure, High, Stress, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,099 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Aug 2006
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 6 Oct 2006 (estimated)
- Results
- Posted 3 Jun 2015
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 affects nearly one third of all individuals in the United States. If left untreated, it can lead to stroke, heart failure, heart attack, kidney failure, or blindness. For many people, the exact cause of high blood pressure is unknown, but it is believed that both genetic and environmental factors contribute to the development of the condition. The purpose of this study is to examine the importance of genetics, inflammation, and stress on the development of high blood pressure.
Detailed description
High blood pressure is a complex condition that can be caused by many factors, including obesity, diet, genetics, or stress. Maintaining a healthy balance of sodium in the body is important for adequate blood pressure control. Some individuals experience sustained high blood pressure during periods of extended stress, combined with the inability to excrete enough sodium through urine to re-establish normal blood pressure levels. This type of stress-induced high blood pressure is related to interleukin-6 (IL-6), a protein that stimulates inflammation and immune responses. To determine the interaction between stress, inflammation, and genetics, this study will examine the role of IL-6 in regulating sodium levels and blood pressure in individuals undergoing stress. This information will be useful in determining new ways to evaluate risk factors for high blood pressure.
This study will examine previously collected DNA samples from young adults who participated in prior genetic studies. There will be no study visits for participants. IL-6, IL-6R, glycoprotein 130 (gp130), and C-reactive protein (CRP) genes will be analyzed in all samples; changes in plasma levels of IL-6 and CRP in response to stress will be examined in selected samples. The parents of participants will be asked to provide cheek swabs for additional DNA analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children | – | Behavioral: Induced StressChildren age 15-19, self reported as African American of European Origin, healthy non-smoker, with normal blood pressure, exposed to an activity to that results in induced stress |
| Parents | – | Procedure: Buccal SwabCollection of buccal swab Parent of participants in the Children Arm |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 15-19 years old African American and European American school children.
Key inclusion criteria (3 listed)
- Participated in two previous NIH funded studies HL073260, HL077230
- Biological parents willing to participate in the study
- African American or European origins
Key exclusion criteria (1 listed)
- Non-biological parents
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 |
|---|---|---|
| Induced StressParticipation in an active coping task by playing a video game against another participant. | Behavioural | Children |
| Buccal SwabOne Buccal swab collected from each parent | Procedure or surgery | Parents |
Primary outcome
Change in Urinary Sodium Excretion (UNaV)
Time frame: Baseline and 4 hour
The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.
1 secondary outcome
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
Time frame: baseline and 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Haidong Zhu, MD, PhD principal investigator
Augusta University
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 Augusta University 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 1 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 3 Jun 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?
Yes. Results are posted in the registry (first posted 3 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Urinary Sodium Excretion (UNaV) (time frame: Baseline and 4 hour). 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 3 Jun 2015.