Abdominal Fat and Imaging Measurements of Heart Disease
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| First Received Date ICMJE | September 27, 2011 | ||||||||
| Last Updated Date | May 23, 2013 | ||||||||
| Start Date ICMJE | March 2012 | ||||||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE |
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 |
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| Change History | Complete list of historical versions of study NCT01447745 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Abdominal Fat and Imaging Measurements of Heart Disease | ||||||||
| Official Title ICMJE | Visceral Obesity/Ectopic Fat and Non-invasive Markers of Atherosclerosis: A Cardiometabolic-cardiovascular Imaging Study | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole blood, serum, plasma, white cells |
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| 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 |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) | 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 |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 500 | ||||||||
| Estimated Completion Date | March 2016 | ||||||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 35 Years to 65 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01447745 | ||||||||
| Other Study ID Numbers ICMJE | CIHR MOP-114920 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Jean-Pierre DESPRÉS, PhD, Laval University | ||||||||
| Study Sponsor ICMJE | Laval University | ||||||||
| Collaborators ICMJE | Canadian Institutes of Health Research (CIHR) | ||||||||
| Investigators ICMJE |
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| Information Provided By | Laval University | ||||||||
| Verification Date | May 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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