Association Between Abdominal Body Composition, Inflammation, and Risk for Cardiovascular Disease (The MESA ABD Study) (MESA ABD)

Abdominal Body Composition, Inflammation, and Cardiovascular Disease

Obesity is a growing public health concern, with approximately 31% of Americans considered obese. The link between abdominal obesity and cardiovascular disease (CVD) has been well established, but the effect of distinct types of abdominal fat tissue on CVD risk is not well known. The rate of obesity and the distribution of abdominal fat differ with age, sex, and ethnicity. These differences may have important implications for determining ethnic-specific relationships between abdominal body composition (ABC), inflammation, and CVD events. This study will evaluate the association between measures of abdominal fat, CVD risk, and inflammation in terms of ethnicity-, sex-, and age-specific differences.

Study Overview

Status

Completed

Detailed Description

Abdominal obesity is a serious condition and increases the risk for potentially life-threatening cardiovascular diseases (CVDs). Abdominal fat is made up of structurally and functionally different tissues, which include visceral fat, subcutaneous fat, and intramuscular fat. The distribution and levels of these fat tissues are highly variable among obese people, and the effects of ABC differences on cardiovascular health are not well known. Notably, the standard measure of body mass index cannot distinguish between different kinds or ratios of tissue types that make up body weight and, therefore, may not be the best measurement tool. Determining the specific measures of these tissue types by computed tomography (CT) may provide better insight into the varied CVD risk seen among different ethnicities, sexes, and ages. This study will evaluate the association between volumetric measures of ABC, CVD risk, and inflammation in terms of ethnicity-, sex-, and age-specific variables.

This substudy will use data and specimens, including blood samples and CT scans, from participants in the Multi-Ethnic Study of Atherosclerosis (MESA) for abdominal aortic calcium (AAC). Stored blood samples will be used to perform assays for several measures of inflammation and to generate new data on biomarkers and subclinical CVD measures. The existing CT scans will be used to calculate five discrete volumetric measures of ABC, which will include subcutaneous fat, visceral fat, intramuscular fat, the visceral fat to visceral cavity ratio, and the lean muscle to visceral fat ratio. There will be no study visits for this study.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Study Type

Observational

Enrollment (Actual)

1975

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego

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

45 years to 84 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will use data and specimens from participants in the MESA study for AAC who have undergone CT scans of the abdomen.

Description

Inclusion Criteria:

  • Participant in the MESA study

Exclusion Criteria:

  • History of cardiovascualar disease

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?

Design Details

Cohorts and Interventions

Group / Cohort
1
Participants from the Multi-Ethnic Study of Atherosclerosis (MESA) for abdominal aortic calcium (AAC) who have undergone computed tomography (CT) scans of the abdomen

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Relationship between abdominal tissue types, levels of inflammatory markers and adipokines, and CVD events
Time Frame: Measured at completion of sample analysis
Measured at completion of sample analysis

Secondary Outcome Measures

Outcome Measure
Time Frame
How differences in age, sex, and ethnicity influence the association between ABC and CVD risk
Time Frame: Measured at completion of sample analysis
Measured at completion of sample analysis

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Matthew A. Allison, MD, MPH, University of California, San Diego

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

September 1, 2007

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

February 7, 2008

First Submitted That Met QC Criteria

February 7, 2008

First Posted (Estimate)

February 11, 2008

Study Record Updates

Last Update Posted (Estimate)

July 29, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

February 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 1419
  • R01HL088451 (U.S. NIH Grant/Contract)

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 Cardiovascular Diseases

3
Subscribe