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

NCT00384241 | Completed Results DMC

• 3 other identifiers: 1359R21HL0858171R21HL085817-01
• Study Type: observational
• Target: 1,099
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Blood Pressure, High; Stress; Inflammation

Outcome Measures

Primary Outcomes (1)

• Change in Urinary Sodium Excretion (UNaV)

  The value of Stress induced UNaV as determined by delta UNaV = stress UNaV - baseline UNaV.

  Baseline and 4 hour

Secondary Outcomes (1)

• The Effect of Change in Stress Induced IL-6 on Systolic Blood Pressure

  baseline and 4 hours

Study Arms (2)

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

Parents

Collection of buccal swab Parent of participants in the Children Arm

Procedure: Buccal Swab

Interventions

Induced Stress BEHAVIORAL

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

Children

Buccal Swab PROCEDURE

One Buccal swab collected from each parent

Parents

Eligibility Criteria

• Age: 15 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

15-19 years old African American and European American school children.

You may qualify if:

• Participated in two previous NIH funded studies HL073260, HL077230
• Biological parents willing to participate in the study
• African American or European origins

You may not qualify if:

• Non-biological parents

Sponsors & Collaborators

• Augusta University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Medical College of Georgia, Georgia Regents University

Augusta, Georgia, 30912, United States

Location

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.

MeSH Terms

Conditions

Hypertension; Inflammation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

No treatment was given.

Results Point of Contact

• Title: Haidong Zhu MD, PhD, Assistant Professor
• Organization: Medical College of Georgia, Georgia Regents University

hzhu@gru.edu

706 721 5470

Study Officials

• Haidong Zhu, MD, PhD

  Augusta University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: August 1, 2006
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: June 3, 2015
• Results First Posted: June 3, 2015

Record last verified: 2015-05

Locations

US (1)