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Abdominal Fat and Imaging Measurements of Heart Disease

26. november 2015 opdateret af: Jean-Pierre DESPRÉS, PhD, Laval University

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.

Studieoversigt

Undersøgelsestype

Observationel

Tilmelding (Forventet)

500

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Quebec
      • Québec, Quebec, Canada, G1V 4G5
        • Rekruttering
        • Institut universitaire de cardiologie et de pneumologie de Quebec
        • Ledende efterforsker:
          • DESPRÉS Jean-Pierre, PhD
        • Underforsker:
          • DAGENAIS Gilles, MD
        • Underforsker:
          • LAMARCHE Benoît, PhD
        • Underforsker:
          • LAROSE Eric, DVM, MD
        • Underforsker:
          • MATHIEU Patrick, MD
        • Underforsker:
          • PIBAROT Philippe, DVM, PhD
        • Underforsker:
          • POIRIER Paul, MD, PhD
        • Underforsker:
          • RHÉAUME Caroline, MD, PhD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

35 år til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
Tidsramme: Change between baseline and 3-year follow-up
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in abdominal adipose tissue measured by computed tomography (CT)
Tidsramme: Change between baseline and 3-year follow-up
Visceral and subcutaneous adipose tissue will be determined at both L2-L3 and L4-L5 levels
Change between baseline and 3-year follow-up
Change in epi- and pericardial fat measured by magnetic resonance imaging (MRI)
Tidsramme: Change between baseline and 3-year follow-up
Change between baseline and 3-year follow-up

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: DESPRÉS Jean-Pierre, PhD, Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. marts 2013

Primær færdiggørelse (Forventet)

1. marts 2017

Studieafslutning (Forventet)

1. marts 2017

Datoer for studieregistrering

Først indsendt

27. september 2011

Først indsendt, der opfyldte QC-kriterier

4. oktober 2011

Først opslået (Skøn)

6. oktober 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

30. november 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. november 2015

Sidst verificeret

1. november 2015

Mere information

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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