- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: DESPRÉS Jean-Pierre, PhD
- 전화번호: 418 656-4863
- 이메일: jean-pierre.despres@criucpq.ulaval.ca
연구 연락처 백업
- 이름: CYR Michèle
- 전화번호: 3602 418 656-8711
- 이메일: michele.cyr@criucpq.ulaval.ca
연구 장소
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Quebec
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Québec, Quebec, 캐나다, G1V 4G5
- 모병
- Institut Universitaire De Cardiologie Et De Pneumologie De Québec
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수석 연구원:
- DESPRÉS Jean-Pierre, PhD
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부수사관:
- DAGENAIS Gilles, MD
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부수사관:
- LAMARCHE Benoît, PhD
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부수사관:
- LAROSE Eric, DVM, MD
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부수사관:
- MATHIEU Patrick, MD
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부수사관:
- PIBAROT Philippe, DVM, PhD
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부수사관:
- POIRIER Paul, MD, PhD
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부수사관:
- RHÉAUME Caroline, MD, PhD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in carotid vessel wall volume measured by magnetic resonance imaging (MRI)
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in abdominal adipose tissue measured by computed tomography (CT)
기간: 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)
기간: Change between baseline and 3-year follow-up
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Change between baseline and 3-year follow-up
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: DESPRÉS Jean-Pierre, PhD, Université Laval/Institut universitaire de cardiologie et de pneumologie de Québec
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .