- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00021879
Visceral Adiposity and CVD Risk in Women
Study Overview
Status
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
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Stephen Daniels, Children's Hospital & Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
-
University College, LondonBritish Heart Foundation; Horizon 2020 - European CommissionRecruitingValvular Heart DiseaseUnited Kingdom