Abdominal Fat and Imaging Measurements of Heart Disease

Metabolic Syndrome Clinical Trial

Official title:

Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01447745
• Other study ID #: CIHR MOP-114920
• Status: Recruiting
• Phase: N/A
• First received: September 27, 2011
• Last updated: November 26, 2015
• Start date: March 2013
• Est. completion date: March 2017

Study information

• Verified date: November 2015
• Source: Laval University
• Contact: DESPRÉS Jean-Pierre, PhD
• Phone: 418 656-4863
• Email: jean-pierre.despres[@]criucpq.ulaval.ca
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Metabolic Syndrome
• Metabolic Syndrome X
• Visceral Obesity

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec	Québec	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Change between baseline and 3-year follow-up	No
Secondary	Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)		Change between baseline and 3-year follow-up	No