Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure - Full Text View

Sponsored by:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00384241

Purpose

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	Phase
Hypertension	Phase I

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth

Resource links provided by NLM:

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Baseline blood pressure, stress blood pressure and recovery blood pressure; baseline, stress and recovery urinary sodium excretion. [ Time Frame: within 4 hour ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pulse wave velocity [ Time Frame: within 4 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Blood samples of 500 subjects have been collected and stored in previous funded studies.

Buccal swabs from 644 biological parents have been collected from the current study.

Enrollment:	644
Study Start Date:	August 2006
Estimated Study Completion Date:	July 2009

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.

Eligibility

Ages Eligible for Study:	15 Years to 19 Years
Genders Eligible for Study:	Both
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 a specified clinical trial for genetic variation in IL-6, IL-6R, gp130, and CRP genes
Biological parents willing to participate in the study
African American or European origins

Exclusion Criteria:

Non-biological parents

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00384241

Locations

United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Haidong Zhu, MD, PhD

Medical College of Georgia

More Information

No publications provided

Responsible Party:	Medical College of Georgia ( Betty Aldridge/Associate Vice President for Research )
Study ID Numbers:	1359, 1 R21 HL085817-01
Study First Received:	October 4, 2006
Last Updated:	April 15, 2009
ClinicalTrials.gov Identifier:	NCT00384241 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

Blood Pressure, High
Stress
Inflammation

Study placed in the following topic categories:

Vascular Diseases
Stress
Inflammation
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on July 06, 2009