Visceral Adiposity and CVD Risk in Women
Primary Purpose
Cardiovascular Diseases, Heart Diseases, Obesity
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
NCT00021879
First Posted
August 10, 2001
Last Updated
February 17, 2016
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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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