Clinical trial NCT01447745: Abdominal Fat and Imaging Measurements of Heart Disease
Official title: Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Visceral Obesity
Atherosclerosis
Metabolic Syndrome
Keywords: Visceral obesity
Cardiometabolic risk
Atherosclerosis
Ectopic fat
Carotid plaque
Magnetic resonance imaging (MRI)
Computed tomography (CT)
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2011-10-06
Enrollment: 500
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Random sample of 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

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.


Eligibility criteria: Inclusion Criteria:

* Men and women aged 35-65 years

Exclusion Criteria:

* Massive obesity (BMI ≥ 40 kg/m2)
* Pharmacological treatment for lipids, hypertension and/or type 2 diabetes
* Clinical signs of cardiovascular disease
* Chronic inflammatory or auto-immune diseases
* Pulmonary diseases on corticosteroids
* Cancers not in remission
* History or clinical evidence of coronary heart disease (CHD)
* History of revascularisation procedures
* Current smoking
* Hormonal replacement therapy

Primary outcomes:
measure: Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
timeFrame: Change between baseline and 3-year follow-up
Secondary outcomes:
measure: Change in abdominal adipose tissue measured by computed tomography (CT)
timeFrame: Change between baseline and 3-year follow-up
measure: Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
timeFrame: Change between baseline and 3-year follow-up
Other outcomes:
Locations:
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec
state: Quebec
Study officials:
affiliation: Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
name: DESPRÉS Jean-Pierre, PhD
role: PRINCIPAL_INVESTIGATOR
References: