Abdominal Fat and Imaging Measurements of Heart Disease

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Visceral Obesity
Atherosclerosis
Metabolic Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum, plasma, white cells


Estimated Enrollment: 500
Study Start Date: March 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447745

Contacts
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

Locations
Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Québec Recruiting
Québec, Quebec, Canada, G1V 4G5
Principal Investigator: DESPRÉS Jean-Pierre, PhD         
Sub-Investigator: DAGENAIS Gilles, MD         
Sub-Investigator: LAMARCHE Benoît, PhD         
Sub-Investigator: LAROSE Eric, DVM, MD         
Sub-Investigator: MATHIEU Patrick, MD         
Sub-Investigator: PIBAROT Philippe, DVM, PhD         
Sub-Investigator: POIRIER Paul, MD, PhD         
Sub-Investigator: RHÉAUME Caroline, MD, PhD         
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: DESPRÉS Jean-Pierre, PhD Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
  More Information

No publications provided

Responsible Party: Jean-Pierre DESPRÉS, PhD, Principal Investigator, Laval University
ClinicalTrials.gov Identifier: NCT01447745     History of Changes
Other Study ID Numbers: CIHR MOP-114920
Study First Received: September 27, 2011
Last Updated: May 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Laval University:
Visceral obesity
Cardiometabolic risk
Atherosclerosis
Ectopic fat
Carotid plaque
Magnetic resonance imaging (MRI)
Computed tomography (CT)

Additional relevant MeSH terms:
Atherosclerosis
Arteriosclerosis
Obesity
Metabolic Syndrome X
Obesity, Abdominal
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014