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20 Year Changes in Fitness & Cardiovascular Disease Risk - Ancillary to CARDIA
This study has been completed.
Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00106457
  Purpose

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.


Condition Phase
Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Metabolic Syndrome X
Hypertension
Obesity
N/A

MedlinePlus related topics: Coronary Artery Disease Diabetes High Blood Pressure Metabolic Syndrome Obesity
U.S. FDA Resources
Study Type: Observational

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 2005
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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]).

  Eligibility

Ages Eligible for Study:   38 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00106457

Sponsors and Collaborators
Investigators
Investigator: Stephen Sidney Kaiser Foundation Research Institute
  More Information

Study ID Numbers: 1290
Study First Received: March 24, 2005
Last Updated: November 13, 2008
ClinicalTrials.gov Identifier: NCT00106457  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Myocardial Ischemia
Overweight
Arteriosclerosis
Body Weight
Signs and Symptoms
Hyperinsulinism
Syndrome X
Nutrition Disorders
Abdominal obesity metabolic syndrome
Arterial Occlusive Diseases
Obesity
Metabolic Diseases
Heart Diseases
Metabolic Syndrome X
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Ischemia
Coronary Disease
Overnutrition
Endocrinopathy
Insulin Resistance
Glucose Metabolism Disorders
Metabolic disorder
Coronary Artery Disease
Hypertension

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009