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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Augusta University

Tracking Information
First Submitted Date October 4, 2006
First Posted Date October 6, 2006
Results First Submitted Date June 21, 2013
Results First Posted Date June 3, 2015
Last Update Posted Date June 3, 2015
Study Start Date August 2006
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 13, 2015)
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.
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures
 (submitted: May 13, 2015)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
Official Title Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
Brief 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. 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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.

Sampling Method Non-Probability Sample
Study Population 15-19 years old African American and European American school children.
Condition Hypertension
Intervention
  • Behavioral: Induced Stress
    Participation in an active coping task by playing a video game against another participant.
  • Procedure: Buccal Swab
    One Buccal swab collected from each parent
Study Groups/Cohorts
  • 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
    Intervention: Behavioral: Induced Stress
  • Parents
    Collection of buccal swab Parent of participants in the Children Arm
    Intervention: Procedure: Buccal Swab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 13, 2015)
1099
Original Enrollment
 (submitted: October 4, 2006)
500
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00384241
Other Study ID Numbers 1359
R21HL085817 ( U.S. NIH Grant/Contract )
1R21HL085817-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Augusta University
Study Sponsor Augusta University
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Haidong Zhu, MD, PhD Augusta University
PRS Account Augusta University
Verification Date May 2015