Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
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|ClinicalTrials.gov Identifier: NCT00384241|
Recruitment Status : Completed
First Posted : October 6, 2006
Results First Posted : June 3, 2015
Last Update Posted : June 3, 2015
|Condition or disease||Intervention/treatment|
|Hypertension||Behavioral: Induced Stress Procedure: Buccal Swab|
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 :||Observational|
|Actual Enrollment :||1099 participants|
|Official Title:||Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth|
|Study Start Date :||August 2006|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
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
Behavioral: Induced Stress
Participation in an active coping task by playing a video game against another participant.
Collection of buccal swab Parent of participants in the Children Arm
Procedure: Buccal Swab
One Buccal swab collected from each parent
- 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.
- 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.
Biospecimen Retention: Samples With DNA
Blood samples of 500 subjects have been collected and stored in previous funded studies.
Buccal swabs from 599 biological parents have been collected from the current study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384241
|United States, Georgia|
|Medical College of Georgia, Georgia Regents University|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Haidong Zhu, MD, PhD||Augusta University|