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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Retrospective
Condition Hypertension
Interventions Behavioral: Induced Stress
Procedure: Buccal Swab
Enrollment 1099
Recruitment Details A study record search was completed on 500 youth for inflammatory marker Interleukin 6 (IL-6), genetic polymorphism and stress induced urinary sodium secretion data. 599 parents of identified subjects were asked to submit Buccal swabs for the analysis of IL-6 genes.
Pre-assignment Details  
Arm/Group Title Children Parents
Hide Arm/Group Description Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study. Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
Period Title: Overall Study
Started 500 599
Completed 500 599
Not Completed 0 0
Arm/Group Title Children Parents Total
Hide Arm/Group Description African American and Caucasian children age 15-19. African American and Caucasian parents, age 18-65. Total of all reporting groups
Overall Number of Baseline Participants 500 599 1099
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 599 participants 1099 participants
<=18 years
500
 100.0%
0
   0.0%
500
  45.5%
Between 18 and 65 years
0
   0.0%
599
 100.0%
599
  54.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 599 participants 1099 participants
Female
236
  47.2%
457
  76.3%
693
  63.1%
Male
264
  52.8%
142
  23.7%
406
  36.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 500 participants 599 participants 1099 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
250
  50.0%
389
  64.9%
639
  58.1%
White
250
  50.0%
210
  35.1%
460
  41.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Change in Urinary Sodium Excretion (UNaV)
Hide Description The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.
Time Frame Baseline and 4 hour
Hide Outcome Measure Data
Hide Analysis Population Description
All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.
Arm/Group Title Children
Hide Arm/Group Description:
500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
Overall Number of Participants Analyzed 500
Mean (Standard Deviation)
Unit of Measure: pg/ml
Baseline 11.8  (5.6)
4 hours 15.2  (7)
2.Secondary Outcome
Title The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
Hide Description 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.
Time Frame baseline and 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.
Arm/Group Title Children
Hide Arm/Group Description:
500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
Overall Number of Participants Analyzed 500
Mean (Standard Deviation)
Unit of Measure: mmHg
Baseline 108.9  (10.1)
4 hours 113.3  (11.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Children Parents
Hide Arm/Group Description African American and Caucasian children age 15 - 19. African American and Caucasian parents age 18 - 65
All-Cause Mortality
Children Parents
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Children Parents
Affected / at Risk (%) Affected / at Risk (%)
Total   0/500 (0.00%)   0/599 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Children Parents
Affected / at Risk (%) Affected / at Risk (%)
Total   0/500 (0.00%)   0/599 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Haidong Zhu MD, PhD, Assistant Professor
Organization: Medical College of Georgia, Georgia Regents University
Phone: 706 721 5470
EMail: hzhu@gru.edu
Layout table for additonal information
Responsible Party: Augusta University
ClinicalTrials.gov Identifier: NCT00384241    
Other Study ID Numbers: 1359
R21HL085817 ( U.S. NIH Grant/Contract )
1R21HL085817-01 ( U.S. NIH Grant/Contract )
First Submitted: October 4, 2006
First Posted: October 6, 2006
Results First Submitted: June 21, 2013
Results First Posted: June 3, 2015
Last Update Posted: June 3, 2015