Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00106457
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
2005-03-24
Brief Title:
20 Year Changes in Fitness Cardiovascular Disease Risk - Ancillary to CARDIA
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-11
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 understand the complex longitudinal relations between physical fitness physical activity body mass and composition and fat distribution and genetic factors and their independent or interactive effects on the development of obesity the metabolic syndrome and sub-clinical cardiovascular disease
Detailed Description:
BACKGROUND
Although an age-related decline in aerobic capacity is well documented the impact of physical activity body fat and genetic variation on the rate of change is not well understood In addition little is known about how rate of change in aerobic capacity during early and middle adulthood affects the development of cardiovascular disease risk factors or the incidence of subclinical and clinical cardiovascular disease CVD related end-points The study addresses these issues by conducting an ancillary study in conjunction with the Year 20 CARDIA Coronary Artery Risk Development in Young Adults examination which is scheduled to take place beginning in June 2005 Approximately 3650 75 of the surviving members of the initial cohort of African American and white men and women will return for the Year 20 exam at which point they will be 38-50 years old
CARDIA is a National Heart Lung and Blood Institute-supported longitudinal study which measures changes in coronary heart disease risk factors in cohorts of Black and white males and females who were 18 to 30 years of age at baseline Also the study identifies life styles during this age span which influence these changes in risk factors
DESIGN NARRATIVE
The overall goal of the ancillary study is to understand the complex longitudinal relations between physical fitness physical activity body mass and composition and fat distribution and genetic factors and their independent or interactive effects on the development of obesity the metabolic syndrome and sub-clinical CVD To accomplish this goal all Year 20 CARDIA participants will be measured for 1 Aerobic capacity by means of a symptom-limited graded exercise treadmill test using the same protocol as that used in CARDIA at the Year 0 and Year 7 exams 2 Body composition and fat distribution using a whole body dual energy x-ray absorptiometery DEXA scan 3 Physical activity using 7 days of accelerometer recordings and 4 DNA sequence variants in selected candidate genes associated with cardiorespiratory fitness components of the metabolic syndrome and response to regular exercise using stored DNA
Data from this ancillary study will be combined with core CARDIA examination data to address the following aims a Examination of the contribution of body mass and composition fat distribution objectively measured physical activity and specific genetic polymorphisms to the variance in Year 20 aerobic capacity and in age-related decline in aerobic capacity over a 20-year time period from young adulthood to mid-life stratifying by race and gender b Longitudinal examination of the effect of aerobic capacity on changes in cardiovascular disease risk factors and on the incidence of CVD-related endpoints eg hypertension metabolic syndrome subclinical disease eg coronary artery calcium
Although an age-related decline in aerobic capacity is well documented the impact of physical activity body fat and genetic variation on the rate of change is not well understood In addition little is known about how rate of change in aerobic capacity during early and middle adulthood affects the development of cardiovascular disease risk factors or the incidence of subclinical and clinical cardiovascular disease CVD related end-points The study addresses these issues by conducting an ancillary study in conjunction with the Year 20 CARDIA Coronary Artery Risk Development in Young Adults examination which is scheduled to take place beginning in June 2005 Approximately 3650 75 of the surviving members of the initial cohort of African American and white men and women will return for the Year 20 exam at which point they will be 38-50 years old
CARDIA is a National Heart Lung and Blood Institute-supported longitudinal study which measures changes in coronary heart disease risk factors in cohorts of Black and white males and females who were 18 to 30 years of age at baseline Also the study identifies life styles during this age span which influence these changes in risk factors
DESIGN NARRATIVE
The overall goal of the ancillary study is to understand the complex longitudinal relations between physical fitness physical activity body mass and composition and fat distribution and genetic factors and their independent or interactive effects on the development of obesity the metabolic syndrome and sub-clinical CVD To accomplish this goal all Year 20 CARDIA participants will be measured for 1 Aerobic capacity by means of a symptom-limited graded exercise treadmill test using the same protocol as that used in CARDIA at the Year 0 and Year 7 exams 2 Body composition and fat distribution using a whole body dual energy x-ray absorptiometery DEXA scan 3 Physical activity using 7 days of accelerometer recordings and 4 DNA sequence variants in selected candidate genes associated with cardiorespiratory fitness components of the metabolic syndrome and response to regular exercise using stored DNA
Data from this ancillary study will be combined with core CARDIA examination data to address the following aims a Examination of the contribution of body mass and composition fat distribution objectively measured physical activity and specific genetic polymorphisms to the variance in Year 20 aerobic capacity and in age-related decline in aerobic capacity over a 20-year time period from young adulthood to mid-life stratifying by race and gender b Longitudinal examination of the effect of aerobic capacity on changes in cardiovascular disease risk factors and on the incidence of CVD-related endpoints eg hypertension metabolic syndrome subclinical disease eg coronary artery calcium
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL078972-04 | NIH | None | httpsreporternihgovquickSearchR01HL078972-04 |