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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00384241
Enrollment
1099
Registered
2006-10-06
Start date
2006-08-31
Completion date
2009-07-31
Last updated
2015-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Blood Pressure, High, Stress, Inflammation

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.

Interventions

BEHAVIORALInduced Stress

Participation in an active coping task by playing a video game against another participant.

PROCEDUREBuccal Swab

One Buccal swab collected from each parent

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Augusta University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Urinary Sodium Excretion (UNaV)Baseline and 4 hourThe value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.

Secondary

MeasureTime frameDescription
The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressurebaseline and 4 hoursStress 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.

Countries

United States

Participant flow

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.

Participants by arm

ArmCount
Children
African American and Caucasian children age 15-19.
500
Parents
African American and Caucasian parents, age 18-65.
599
Total1,099

Baseline characteristics

CharacteristicChildrenParentsTotal
Age, Categorical
<=18 years
500 Participants0 Participants500 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants599 Participants599 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
250 Participants389 Participants639 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
250 Participants210 Participants460 Participants
Sex: Female, Male
Female
236 Participants457 Participants693 Participants
Sex: Female, Male
Male
264 Participants142 Participants406 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 5000 / 599
serious
Total, serious adverse events
0 / 5000 / 599

Outcome results

Primary

Change in Urinary Sodium Excretion (UNaV)

The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.

Time frame: Baseline and 4 hour

Population: All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.

ArmMeasureGroupValue (MEAN)Dispersion
ChildrenChange in Urinary Sodium Excretion (UNaV)Baseline11.8 pg/mlStandard Deviation 5.6
ChildrenChange in Urinary Sodium Excretion (UNaV)4 hours15.2 pg/mlStandard Deviation 7
Secondary

The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure

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

Population: All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents.

ArmMeasureGroupValue (MEAN)Dispersion
ChildrenThe Effect of Change in Stress Induced IL-6 on Systolic Blood PressureBaseline108.9 mmHgStandard Deviation 10.1
ChildrenThe Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure4 hours113.3 mmHgStandard Deviation 11.9

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026