Trial Outcomes & Findings for Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure (NCT NCT00384241)
NCT ID: NCT00384241
Last Updated: 2015-06-03
Results Overview
The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.
COMPLETED
1099 participants
Baseline and 4 hour
2015-06-03
Participant Flow
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.
Participant milestones
| Measure |
Children
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.
|
Parents
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.
|
|---|---|---|
|
Overall Study
STARTED
|
500
|
599
|
|
Overall Study
COMPLETED
|
500
|
599
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
Baseline characteristics by cohort
| Measure |
Children
n=500 Participants
African American and Caucasian children age 15-19.
|
Parents
n=599 Participants
African American and Caucasian parents, age 18-65.
|
Total
n=1099 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
500 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
500 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
599 Participants
n=4 Participants
|
599 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
236 Participants
n=93 Participants
|
457 Participants
n=4 Participants
|
693 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
264 Participants
n=93 Participants
|
142 Participants
n=4 Participants
|
406 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
250 Participants
n=93 Participants
|
389 Participants
n=4 Participants
|
639 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
250 Participants
n=93 Participants
|
210 Participants
n=4 Participants
|
460 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline and 4 hourPopulation: All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.
The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.
Outcome measures
| Measure |
Children
n=500 Participants
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
|
|---|---|
|
Change in Urinary Sodium Excretion (UNaV)
Baseline
|
11.8 pg/ml
Standard Deviation 5.6
|
|
Change in Urinary Sodium Excretion (UNaV)
4 hours
|
15.2 pg/ml
Standard Deviation 7
|
SECONDARY outcome
Timeframe: baseline and 4 hoursPopulation: All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.
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.
Outcome measures
| Measure |
Children
n=500 Participants
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
|
|---|---|
|
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
Baseline
|
108.9 mmHg
Standard Deviation 10.1
|
|
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
4 hours
|
113.3 mmHg
Standard Deviation 11.9
|
Adverse Events
Children
Parents
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Haidong Zhu MD, PhD, Assistant Professor
Medical College of Georgia, Georgia Regents University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place