Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
Hypertension Behavioral: Induced Stress Procedure: Buccal Swab

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1099 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
Study Start Date : August 2006
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
Behavioral: Induced Stress
Participation in an active coping task by playing a video game against another participant.

Parents
Collection of buccal swab Parent of participants in the Children Arm
Procedure: Buccal Swab
One Buccal swab collected from each parent




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
15-19 years old African American and European American school children.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384241


Locations
Layout table for location information
United States, Georgia
Medical College of Georgia, Georgia Regents University
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Layout table for investigator information
Principal Investigator: Haidong Zhu, MD, PhD Augusta University
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 Posted: October 6, 2006    Key Record Dates
Results First Posted: June 3, 2015
Last Update Posted: June 3, 2015
Last Verified: May 2015
Keywords provided by Augusta University:
Blood Pressure, High
Stress
Inflammation
Additional relevant MeSH terms:
Layout table for MeSH terms
Hypertension
Inflammation
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes