Abdominal Fat and Imaging Measurements of Heart Disease

This study is currently recruiting participants.
Verified May 2013 by Laval University
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Jean-Pierre DESPRÉS, PhD, Laval University
ClinicalTrials.gov Identifier:
NCT01447745
First received: September 27, 2011
Last updated: May 23, 2013
Last verified: May 2013

September 27, 2011
May 23, 2013
March 2012
March 2016   (final data collection date for 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 ] [ Designated as safety issue: No ]
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
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]
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
Complete list of historical versions of study NCT01447745 on ClinicalTrials.gov Archive Site
  • Change in abdominal adipose tissue measured by computed tomography (CT) [ Time Frame: Change between baseline and 3-year follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Change between baseline and 3-year follow-up ] [ Designated as safety issue: No ]
  • Change in abdominal adipose tissue measured by computed tomography (CT) [ Time Frame: Baseline and 3-years follow-up ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 3-year follow-up ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood, serum, plasma, white cells

Non-Probability Sample

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

  • Visceral Obesity
  • Atherosclerosis
  • Metabolic Syndrome
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
March 2016
March 2016   (final data collection date for primary outcome measure)

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
Both
35 Years to 65 Years
Yes
Contact: DESPRÉS Jean-Pierre, PhD 418 656-4863 jean-pierre.despres@criucpq.ulaval.ca
Contact: CYR Michèle 418 656-8711 ext 3602 michele.cyr@criucpq.ulaval.ca
Canada
 
NCT01447745
CIHR MOP-114920
No
Jean-Pierre DESPRÉS, PhD, Laval University
Laval University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: DESPRÉS Jean-Pierre, PhD Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
Laval University
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP