Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064506
Status:
COMPLETED
Last Update Posted:
2021-10-01
First Post:
2003-07-08
Brief Title:
Gene-Environment Interactions in Complex Disease
Sponsor:
The University of Texas Health Science Center Houston
Organization:
The University of Texas Health Science Center Houston
Study Overview
Official Title:
Gene-Environment Interactions in Complex Disease
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 eg race and gender and environmental eg 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 11625 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 eg total kcals Keys score alcohol intake obesity measures of physical activity sport leisure and work indices smoking and menopause statushormone use women only Outcome variables will include measures of quantitative risk factors eg 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
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 eg race and gender and environmental eg 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 11625 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 eg total kcals Keys score alcohol intake obesity measures of physical activity sport leisure and work indices smoking and menopause statushormone use women only Outcome variables will include measures of quantitative risk factors eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL073366 | NIH | None | httpsreporternihgovquickSearchR01HL073366 |