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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by National Heart, Lung, and Blood Institute (NHLBI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00612365
First received: February 7, 2008
Last updated: February 10, 2009
Last verified: February 2009
  Purpose

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.


Condition
Cardiovascular Diseases
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Abdominal Body Composition, Inflammation, and Cardiovascular Disease

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • Relationship between abdominal tissue types, levels of inflammatory markers and adipokines, and CVD events [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • How differences in age, sex, and ethnicity influence the association between ABC and CVD risk [ Time Frame: Measured at completion of sample analysis ] [ Designated as safety issue: No ]

Enrollment: 1975
Study Start Date: September 2007
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   45 Years to 84 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

  • Participant in the MESA study

Exclusion Criteria:

  • History of cardiovascualar disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00612365

Locations
United States, California
University of California San Diego
La Jolla, California, United States, 92093
Sponsors and Collaborators
Investigators
Principal Investigator: Matthew A. Allison, MD, MPH University of California, San Diego
  More Information

No publications provided

Responsible Party: Matthew A. Allison, University of California San Diego
ClinicalTrials.gov Identifier: NCT00612365     History of Changes
Other Study ID Numbers: 1419, HL088451
Study First Received: February 7, 2008
Last Updated: February 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Body Composition
Abdomen
Atherosclerosis

Additional relevant MeSH terms:
Cardiovascular Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014