Gene-Environment Interactions in Complex Disease

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT00064506
Collaborator
National Heart, Lung, and Blood Institute (NHLBI) (NIH)
15,792
46

Study Details

Study Description

Brief Summary

To assess genetic variation in 87 different cardiovascular disease candidate genes and to measure the associations of these variants with cardiovascular disease and its risk factors.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    BACKGROUND:

    Cardiovascular disease (CVD), the number one cause of death in industrialized countries today is a complex disease with a multifactorial etiology involving many genetic and environmental factors. Public health prevention programs designed to reduce the risk and occurrence of CVD commonly focus on modifiable environments and behaviors such as diet and physical activity, with varied results among individuals. This heterogeneity in response to CVD interventions is at least in part of genetic origin. Although a number of candidate genes have been identified which appear to influence the development of CVD, little is known about how these genetic effects may vary within demographic (e.g., race and gender) and environmental (e.g., diet and exercise) contexts; thus, it is of utmost importance to determine how genes and environments interact to produce CVD.

    DESIGN NARRATIVE:

    The purpose of this study is to characterize the environment-dependent effects of 87 biologic and positional candidate genes in a population-based sample of 11,625 African-American and Caucasian men and women from the Atherosclerosis Risk in Communities (ARIC) study. Candidate loci were selected based on confirmed functional significance, consistent association with CVD or its risk factors, and or identified as positional candidates in genome-wide linkage scans. Environmental contexts will focus on dietary measures (e.g., total kcals, Keys score, alcohol intake), obesity, measures of physical activity (sport, leisure, and work indices), smoking, and menopause status/hormone use (women only). Outcome variables will include measures of quantitative risk factors (e.g., total cholesterol, BMI, blood pressure), subclinical disease (carotid wall thickness), and clinical disease (incident coronary heart disease (CHD) and stroke). Existing DNA samples will be used for genotyping of candidate loci, and no further contact with study participants will be necessary. The ARIC cohort, because of its large size and wealth of environmental and physiological measures, provides an ideal, timely, and efficient opportunity to evaluate the effects of modifiable environments on genetic variation which may influence CVD risk and disease outcomes with the ultimate goal of establishing more efficacious programs for the treatment and prevention of CVD.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    15792 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Gene-Environment Interactions in Complex Disease
    Study Start Date :
    Jul 1, 2003
    Actual Primary Completion Date :
    May 1, 2007
    Actual Study Completion Date :
    May 1, 2007

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      45 Years to 65 Years
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No

      No eligibility criteria

      Contacts and Locations

      Locations

      No locations specified.

      Sponsors and Collaborators

      • The University of Texas Health Science Center, Houston
      • National Heart, Lung, and Blood Institute (NHLBI)

      Investigators

      • Principal Investigator: Eric Boerwinkle, University of Texas

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      Eric Boerwinkle, ◦Professor & Director, Division of Epidemiology & Kozmetsky Family Chair In Human Genetics, The University of Texas Health Science Center, Houston
      ClinicalTrials.gov Identifier:
      NCT00064506
      Other Study ID Numbers:
      • 1224
      • R01HL073366
      First Posted:
      Jul 10, 2003
      Last Update Posted:
      Oct 1, 2021
      Last Verified:
      Sep 1, 2021

      Study Results

      No Results Posted as of Oct 1, 2021