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Completed

NCT Number: NCT00612365

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

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.

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Key information

Age range

45 year–84 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Diego

La Jolla, California, 92093, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participant in the MESA study

Exclusion criteria

  • History of cardiovascualar disease

Treatment and study plan

Primary outcomes

  1. Relationship between abdominal tissue types, levels of inflammatory markers and adipokines, and CVD events

    Time frame: Measured at completion of sample analysis

Secondary outcomes

  1. How differences in age, sex, and ethnicity influence the association between ABC and CVD risk

    Time frame: Measured at completion of sample analysis

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Official study title

Abdominal Body Composition, Inflammation, and Cardiovascular Disease

Acronym: MESA ABD

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Feb 11, 2008
Registry last updated
Jul 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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