Abdominal Fat and Imaging Measurements of Heart Disease

Sponsor

Laval University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01447745

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

500

Enrollment

Location

Duration (Months)

10.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Although it is frequently mentioned in the media that overweight and obesity have reached epidemic proportions worldwide and in this country, some Canadians are perplexed and sometimes confused about the role of obesity in diabetes and heart disease. In fact, the investigators even hear from time to time that there could be "healthy" obese individuals. In clinical practice, assessment of obesity as a risk factor for cardiovascular disease (CVD) remains a challenge as even some physicians are confused. However, studies conducted in our laboratory and by other research teams around the world over the last 20 years have clearly shown that body shape is more important than body size when evaluating the risk of overweight/obesity and that high accumulation of abdominal fat (excess belly fat) increases the risk of diabetes and cardiovascular disease (CVD).

The investigators now need to better understand the link between excess belly fat and atherosclerosis (the thickening of artery walls by fatty deposits, also referred to as atherosclerotic plaque), leading to complications such as angina (chest pain) and myocardial infarction (heart attacks). Using non-invasive imaging techniques such as magnetic resonance imaging, the investigators therefore propose to examine the relationships between measures of fatness and of abdominal fat and the size of atherosclerotic plaque in large blood vessels of apparently healthy human subjects. This study is also a unique opportunity to look, for the first time, at the relationship between belly fat, blood sugar, several well-known risk factors for heart disease (cholesterol, blood pressure, cardiorespiratory fitness, etc.) and the size of atherosclerotic plaques. This research program should pave the way to the development of new improved preventive/therapeutic approaches focusing not on body weight but rather on abdominal fat and associated blood abnormalities which are predictive of the development of atherosclerotic plaques leading to the premature development of heart disease.

Condition or Disease	Intervention/Treatment	Phase
Visceral Obesity Atherosclerosis Metabolic Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

500 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study

Study Start Date :

Mar 1, 2013

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Mar 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Observational, longitudinal study Adult men and women representative of the population of asymptomatic adult men and women aged from 35-65 years living in the Québec City metropolitan area

Outcome Measures

Primary Outcome Measures

Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI) [Change between baseline and 3-year follow-up]
Cross-sectional and longitudinal analyses of the relationships between indices of body fat distribution, visceral adiposity/ectopic fat deposition, cardiorespiratory fitness and non-invasive measurements of macrovascular atherosclerosis

Secondary Outcome Measures

Change in abdominal adipose tissue measured by computed tomography (CT) [Change between baseline and 3-year follow-up]
Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels
Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI) [Change between baseline and 3-year follow-up]