NCT01447745

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
357

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 6, 2011

Completed
1.4 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

6.9 years

First QC Date

September 27, 2011

Last Update Submit

September 3, 2025

Conditions

Keywords

Visceral obesityCardiometabolic riskAtherosclerosisEctopic fatCarotid plaqueMagnetic resonance imaging (MRI)Computed tomography (CT)

Outcome Measures

Primary Outcomes (1)

  • 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

    Change between baseline and 3-year follow-up

Secondary Outcomes (2)

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

    Change between baseline and 3-year follow-up

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

    Change between baseline and 3-year follow-up

Study Arms (1)

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 Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Men and women aged 35-65 years

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Québec

Québec, G1V 4G5, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma, white cells

MeSH Terms

Conditions

Obesity, AbdominalAtherosclerosisMetabolic Syndrome

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • DESPRÉS Jean-Pierre, PhD

    Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 27, 2011

First Posted

October 6, 2011

Study Start

March 1, 2013

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

September 10, 2025

Record last verified: 2025-09

Locations