NCT00612365

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,975

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 7, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2008

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

July 29, 2016

Status Verified

February 1, 2009

Enrollment Period

4.9 years

First QC Date

February 7, 2008

Last Update Submit

July 28, 2016

Conditions

Keywords

Body CompositionAbdomenAtherosclerosis

Outcome Measures

Primary Outcomes (1)

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

    Measured at completion of sample analysis

Secondary Outcomes (1)

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

    Measured at completion of sample analysis

Study Arms (1)

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

Eligibility Criteria

Age45 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Participant in the MESA study

You may not qualify if:

  • History of cardiovascualar disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

Cardiovascular DiseasesObesityAtherosclerosis

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Matthew A. Allison, MD, MPH

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

February 7, 2008

First Posted

February 11, 2008

Study Start

September 1, 2007

Primary Completion

August 1, 2012

Study Completion

June 1, 2013

Last Updated

July 29, 2016

Record last verified: 2009-02

Locations