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OpenTrials
Completed

NCT Number: NCT00384241

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

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.

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Key information

Age range

15 year–19 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical College of Georgia, Georgia Regents University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Induced Stress

Behavioral

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

Buccal swab

Procedure

One Buccal swab collected from each parent

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 6, 2006
Registry last updated
Jun 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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