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

Tracking Information

First Received Date ^ICMJE

October 4, 2006

Last Updated Date

April 15, 2009

Start Date ^ICMJE

August 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00384241 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth

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.

Study Phase

Phase I

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Retrospective

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

644

Estimated Completion Date

July 2009

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

15 Years to 19 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00384241

Responsible Party

Betty Aldridge/Associate Vice President for Research, Medical College of Georgia

Study ID Numbers ^ICMJE

1359, 1 R21 HL085817-01

Study Sponsor ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Haidong Zhu, MD, PhD

Medical College of Georgia

Information Provided By

National Heart, Lung, and Blood Institute (NHLBI)

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP