- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01447745
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.
Studienübersicht
Status
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Quebec
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Québec, Quebec, Kanada, G1V 4G5
- Rekrutierung
- Institut Universitaire de Cardiologie et de Pneumologie de Quebec
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Hauptermittler:
- DESPRÉS Jean-Pierre, PhD
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Unterermittler:
- DAGENAIS Gilles, MD
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Unterermittler:
- LAMARCHE Benoît, PhD
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Unterermittler:
- LAROSE Eric, DVM, MD
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Unterermittler:
- MATHIEU Patrick, MD
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Unterermittler:
- PIBAROT Philippe, DVM, PhD
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Unterermittler:
- POIRIER Paul, MD, PhD
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Unterermittler:
- RHÉAUME Caroline, MD, PhD
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Zeitfenster: Change between baseline and 3-year follow-up
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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 between baseline and 3-year follow-up
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Change in abdominal adipose tissue measured by computed tomography (CT)
Zeitfenster: Change between baseline and 3-year follow-up
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Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels
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Change between baseline and 3-year follow-up
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Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
Zeitfenster: Change between baseline and 3-year follow-up
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Change between baseline and 3-year follow-up
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: DESPRÉS Jean-Pierre, PhD, Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Herz-Kreislauf-Erkrankungen
- Gefäßerkrankungen
- Störungen des Glukosestoffwechsels
- Stoffwechselerkrankungen
- Arteriosklerose
- Arterielle Verschlusskrankheiten
- Überernährung
- Ernährungsstörungen
- Übergewicht
- Körpergewicht
- Insulinresistenz
- Hyperinsulinismus
- Fettleibigkeit
- Metabolisches Syndrom
- Atherosklerose
- Fettleibigkeit, Bauch
Andere Studien-ID-Nummern
- CIHR MOP-114920
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