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NCT Number: NCT01447745

Abdominal Fat and Imaging Measurements of Heart Disease

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Primary outcomes

  1. Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)

    Time frame: 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 outcomes

  1. Change in abdominal adipose tissue measured by computed tomography (CT)

    Time frame: Change between baseline and 3-year follow-up

    Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels

  2. Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)

    Time frame: Change between baseline and 3-year follow-up

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2020
Study completion
2020
First posted
Oct 6, 2011
Registry last updated
Sep 10, 2025

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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