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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03397407
Other study ID # AugustaU
Secondary ID
Status Completed
Phase N/A
First received December 18, 2017
Last updated January 10, 2018
Start date August 1, 2001
Est. completion date January 1, 2005

Study information

Verified date January 2018
Source Augusta University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Adiposity is a key link between lifestyle factors (like diet and exercise) and cardiovascular (CV) disease. However, little is known about the link during the juvenile years, when the processes leading to CV disease are at an early stage of development. The specific aims are as follow: (1) to determine the relations of free-living diet and exercise to total body percent fat ( percentBF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status. (2) to determine the relations of fatness and fitness to different CV disease risk factors. Design and methods: (1) Recruit 800 14 to 18 year olds, 200 in each ethnicity and gender subgroup. (2) Assess diet with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring. (3) Measure percent body fat with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. (4) Measure major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). (5) Conduct multivariate and univariate analyses to determine relationships.


Description:

Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other. However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development. The specific aims are as follow: (1) to determine the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status. (2) to determine the relations of fatness and fitness to different CV risk factors. Design and methods: (1) Recruit 800 14 to 18 year olds, 200 in each ethnicity and gender subgroup. (2) Assess diet with seven 24-hour recalls, and exercise with two seven-day recalls and Actigraph monitors. (3) Measure percent body fat with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. (4) Measure major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). (5) Conduct multivariate and univariate analyses to determine relationships. Health relatedness: The provided by this project will assist in the formulation of effective lifestyle interventions targeted to specific demographic groups for primary prevention of CV disease, starting early in life when the foundations for adult disease are being laid.


Recruitment information / eligibility

Status Completed
Enrollment 796
Est. completion date January 1, 2005
Est. primary completion date July 31, 2004
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 14 Years to 18 Years
Eligibility Inclusion Criteria:

- European or African American and age 14-18 years

Exclusion Criteria:

- Taking medications or had any chronic medical conditions that might affect growth, maturation, physical activity, nutritional status, or metabolism.

Study Design


Intervention

Other:
No intervention


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Augusta University

Outcome

Type Measure Description Time frame Safety issue
Primary Fatness Percentage of body fat (%) Through study completion, an average of 4 years
Primary Fitness Maximal oxygen consumption (VO2, mL/kg/min) Through study completion, an average of 4 years
Primary Insulin resistance Fasting insulin (pmol/L) Through study completion, an average of 4 years
Secondary Fat distribution Visceral adipose tissue volume (cm^3) Through study completion, an average of 4 years
Secondary Cardiovascular risk factor Triglyceride (TG, mmol/L) and high density lipoprotein cholesterol (HDLC, mmol/L) will be combined to report TG/HDLC ratio Through study completion, an average of 4 years
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