- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384241
Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Georgia
-
Augusta, Georgia, United States, 30912
- Medical College of Georgia, Georgia Regents University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participated in two previous NIH funded studies HL073260, HL077230
- Biological parents willing to participate in the study
- African American or European origins
Exclusion Criteria:
- Non-biological parents
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
Participation in an active coping task by playing a video game against another participant.
|
Parents
Collection of buccal swab Parent of participants in the Children Arm
|
One Buccal swab collected from each parent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 4 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
Time Frame: baseline and 4 hours
|
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.
|
baseline and 4 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Haidong Zhu, MD, PhD, Augusta University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1359
- R21HL085817 (U.S. NIH Grant/Contract)
- 1R21HL085817-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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