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Visceral Adiposity and CVD Risk in Women

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

23 Years - 25 Years (Adult)FemaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    August 10, 2001
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00021879
    Brief Title
    Visceral Adiposity and CVD Risk in Women
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2001 (undefined)
    Primary Completion Date
    February 2006 (Actual)
    Study Completion Date
    February 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    Brief Summary
    To investigate the influence of total body fat and visceral fat on risk factors of diabetes and cardiovascular disease (CVD) in black and white women.
    Detailed Description
    BACKGROUND: Obesity is associated with increased morbidity and mortality. Concern about obesity has increased as the prevalence and severity have increased and the age of onset has decreased. It has also become clear that the location of fat may play an important role in determining the risk associated with obesity. Intra-abdominal fat has been shown to have particularly adverse consequences related to cardiovascular risk factors. Of interest is the fact that a number of studies have shown that the impact of overall adiposity differs by race. For each unit increase in adiposity, blacks appear to have less of an increase in blood pressure and triglycerides and less of a decrease in HDL cholesterol compared to whites. This racial difference in the relationship of adiposity to cardiovascular risk status may be related to differences in the distribution of fat. It is hypothesized that for a given level and increase in total body fat (measured by DEXA) black women will have less intra-abdominal fat (measured by magnetic resonance imaging). The cohort to be studied is a defined group of black and white women who were initially recruited into the study as children at age nine or 10 years as part of the National Heart, Lung and Blood Institute National Growth and Health Study. The cohort has been maintained and studied continuously over the past 11 to 12 years with about 75 percent of the original cohort remaining. DESIGN NARRATIVE: Subjects will be studied at age 23 and again at age 25 years. At each examination, subjects will have measurement of total fat (DEXA), intra-abdominal fat (MRI), fasting lipids and lipoproteins, insulin and glucose, blood pressure, and left ventricular mass (by echocardiography). In addition, the timing of pubertal maturation and dietary intake of fat and sucrose will be evaluated as potential determinants of intra-abdominal fat using data previously collected from age nine years to age 22 years. Study of this cohort provides a unique opportunity to evaluate whether differences in deposition of intraabdominal fat are related to racial differences in the relationship between adiposity and cardiovascular risk factors. It will also allow evaluation of childhood and adolescent determinants of adult intra-abdominal adiposity. The results of this investigation may provide insight into the prevention of intra-abdominal fat accumulation and ultimate lowering of risk for cardiovascular disease.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Obesity, Diabetes Mellitus

    7. Study Design

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    23 Years
    Maximum Age & Unit of Time
    25 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Stephen Daniels
    Organizational Affiliation
    Children's Hospital & Medical Center

    12. IPD Sharing Statement

    Learn more about this trial

    Visceral Adiposity and CVD Risk in Women

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