Visceral Adiposity and CVD Risk in Women

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.

Study Overview

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.

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

No eligibility criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Stephen Daniels, Children's Hospital & Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2001

Primary Completion (Actual)

February 1, 2006

Study Completion (Actual)

February 1, 2006

Study Registration Dates

First Submitted

August 10, 2001

First Submitted That Met QC Criteria

August 9, 2001

First Posted (Estimate)

August 10, 2001

Study Record Updates

Last Update Posted (Estimate)

February 18, 2016

Last Update Submitted That Met QC Criteria

February 17, 2016

Last Verified

January 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 972
  • R01HL066430 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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