Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00106457 |
| Other study ID # |
1290 |
| Secondary ID |
R01HL078972-04 |
| Status |
Completed |
| Phase |
N/A
|
| First received |
March 24, 2005 |
| Last updated |
July 11, 2016 |
| Start date |
February 2005 |
| Est. completion date |
November 2008 |
Study information
| Verified date |
November 2008 |
| Source |
National Heart, Lung, and Blood Institute (NHLBI) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
United States: Federal Government |
| Study type |
Observational
|
Clinical Trial 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.
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 3,650 (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 (e.g. hypertension,
metabolic syndrome, subclinical disease [e.g. coronary artery calcium]).
