20 Year Changes in Fitness & Cardiovascular Disease Risk - Ancillary to CARDIA
Primary Purpose
Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00106457
First Posted
March 24, 2005
Last Updated
July 11, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00106457
Brief Title
20 Year Changes in Fitness & Cardiovascular Disease Risk - Ancillary to CARDIA
Study Type
Observational
2. Study Status
Record Verification Date
November 2008
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
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 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]).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Coronary Disease, Diabetes Mellitus, Metabolic Syndrome X, Hypertension, Obesity
7. Study Design
10. Eligibility
Sex
All
Minimum Age & Unit of Time
38 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Sidney
Organizational Affiliation
Kaiser Foundation Research Institute
12. IPD Sharing Statement
Citations:
PubMed Identifier
24088719
Citation
Shikany JM, Jacobs DR Jr, Lewis CE, Steffen LM, Sternfeld B, Carnethon MR, Richman JS. Associations between food groups, dietary patterns, and cardiorespiratory fitness in the Coronary Artery Risk Development in Young Adults study. Am J Clin Nutr. 2013 Dec;98(6):1402-9. doi: 10.3945/ajcn.113.058826. Epub 2013 Oct 2.
Results Reference
derived
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20 Year Changes in Fitness & Cardiovascular Disease Risk - Ancillary to CARDIA
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