- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01447745
Abdominal Fat and Imaging Measurements of Heart Disease
Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Québec, Canada, G1V 4G5
- Institut universitaire de Cardiologie et de Pneumologie de Quebec
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Time Frame: Change between baseline and 3-year follow-up
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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
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Change between baseline and 3-year follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in abdominal adipose tissue measured by computed tomography (CT)
Time Frame: Change between baseline and 3-year follow-up
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Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels
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Change between baseline and 3-year follow-up
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Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
Time Frame: Change between baseline and 3-year follow-up
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Change between baseline and 3-year follow-up
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: DESPRÉS Jean-Pierre, PhD, Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Vascular Diseases
- Cardiovascular Diseases
- Nutrition Disorders
- Metabolic Diseases
- Overnutrition
- Body Weight
- Glucose Metabolism Disorders
- Insulin Resistance
- Hyperinsulinism
- Overweight
- Arteriosclerosis
- Arterial Occlusive Diseases
- Obesity
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Metabolic Syndrome
- Atherosclerosis
- Obesity, Abdominal
Other Study ID Numbers
- CIHR MOP-114920
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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