Clinical trial NCT00384241: Evaluating the Relationship Between Inflammation, Genetics, and Stress in the Development of High Blood Pressure
Official title: Inflammatory Factors, Genes and Stress Induced Pressure Natriuresis in Youth
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Keywords: Blood Pressure, High
Stress
Inflammation
Lead sponsor: Augusta University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2006-10-06
Enrollment: 1099
Sex: ALL
Minimum age (years): 15
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 15-19 years old African American and European American school children.

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.

Eligibility 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

Primary outcomes:
measure: Change in Urinary Sodium Excretion (UNaV)
timeFrame: Baseline and 4 hour
Secondary outcomes:
measure: The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure
timeFrame: baseline and 4 hours
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Medical College of Georgia, Georgia Regents University
state: Georgia
Study officials:
affiliation: Augusta University
name: Haidong Zhu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: