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| ID | Type | Description | Link |
|---|---|---|---|
| R21HL085817 | U.S. NIH Grant/Contract | View source | |
| 1R21HL085817-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| Parents | Collection of buccal swab Parent of participants in the Children Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induced Stress | Behavioral | Participation in an active coping task by playing a video game against another participant. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urinary Sodium Excretion (UNaV) | The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV. | Baseline and 4 hour |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 4 hours |
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Inclusion Criteria:
Exclusion Criteria:
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15-19 years old African American and European American school children.
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| Name | Affiliation | Role |
|---|---|---|
| Haidong Zhu, MD, PhD | Augusta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical College of Georgia, Georgia Regents University | Augusta | Georgia | 30912 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Children | African American and Caucasian children age 15-19. |
| BG001 | Parents | African American and Caucasian parents, age 18-65. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Urinary Sodium Excretion (UNaV) | The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV. | All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents. | Posted | Mean | Standard Deviation | pg/ml | Baseline and 4 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children | African American and Caucasian children age 15 - 19. |
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No treatment was given.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Haidong Zhu MD, PhD, Assistant Professor | Medical College of Georgia, Georgia Regents University | 706 721 5470 | hzhu@gru.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
| Buccal Swab | Procedure | One Buccal swab collected from each parent |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| 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. | All 500 subjects in the group Children were analyzed. This data was not intended to be analyzed for Arm 2 Parents. | Posted | Mean | Standard Deviation | mmHg | baseline and 4 hours |
|
|
|
| 0 |
| 500 |
| 0 |
| 500 |
| EG001 | Parents | African American and Caucasian parents age 18 - 65 | 0 | 599 | 0 | 599 |
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