Visceral ObesityNCT01447745
Abdominal Fat and Imaging Measurements of Heart Disease
An observational study of Visceral Obesity and Atherosclerosis, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Visceral Obesity, Atherosclerosis, Metabolic Syndrome
- How many people
- 357 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2013to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- Men and women aged 35-65 years
Who cannot join
- 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
Show all 10Show fewer
- History or clinical evidence of coronary heart disease (CHD)
- History of revascularisation procedures
- Current smoking
- Hormonal replacement therapy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Institut universitaire de cardiologie et de pneumologie de Québec
Québec, G1V 4G5
About this study
Official title: 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.
- Conditions
- Visceral Obesity, Atherosclerosis, Metabolic Syndrome
- Keywords
- Visceral obesity, Cardiometabolic risk, Atherosclerosis, Ectopic fat, Carotid plaque, Magnetic resonance imaging (MRI), Computed tomography (CT)
- Medical subject headings
- Obesity, Abdominal, Atherosclerosis, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
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
Measured: Change between baseline and 3-year follow-up
Secondary outcomes (2)
Change in abdominal adipose tissue measured by computed tomography (CT)
Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels
Measured: Change between baseline and 3-year follow-up
Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
Measured: Change between baseline and 3-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startMar 2013
- Primary completionFeb 2020
- Study completionFeb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visceral ObesityStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 357 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Jean-Pierre DESPRÉS, PhD, Laval University
- Investigators
- DESPRÉS Jean-Pierre, PhD, Principal investigator, Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447745
- Sponsor's protocol ID
- CIHR MOP-114920
- Status last verified
- Sep 2025
- First submitted
- 27 Sep 2011
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study
- ClinicalTrials.gov ID
- NCT01447745
- Acronym / sponsor ID
- CIHR MOP-114920
- Conditions
- Visceral Obesity, Atherosclerosis, Metabolic Syndrome
- Keywords
- Visceral obesity, Cardiometabolic risk, Atherosclerosis, Ectopic fat, Carotid plaque, Magnetic resonance imaging (MRI), Computed tomography (CT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 357 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2013 (actual)
- Primary completion
- Feb 2020 (actual)
- Study completion
- Feb 2020 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Men and women aged 35-65 years
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Change in abdominal adipose tissue measured by computed tomography (CT)
Time frame: Change between baseline and 3-year follow-up
Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
Time frame: Change between baseline and 3-year follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DESPRÉS Jean-Pierre, PhD principal investigator
Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visceral Obesity and Atherosclerosis, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI) (time frame: Change between baseline and 3-year follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.