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Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by Ziv Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ziv Hospital
ClinicalTrials.gov Identifier:
NCT01282892
First received: January 18, 2011
Last updated: January 24, 2011
Last verified: January 2011

January 18, 2011
January 24, 2011
February 2009
November 2009   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT01282892 on ClinicalTrials.gov Archive Site
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Not Provided
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Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis
Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis

Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a condition carrying a high risk of coronary artery disease. The independent role of Visceral Fat in cardiovascular risk remains unclear.

Patients with excess of visceral fat and NAFLD patients will have higher prevalence of coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting that the presence of visceral fat and/or fatty liver will be considered an important condition to optimize the cardiovascular risk stratification

Abstract Background: Visceral fat or peri-omental fat is increasingly associated with metabolic syndrome, a condition carrying a high risk of coronary artery disease. The independent role of Visceral Fat in cardiovascular risk remains unclear. Aim: Evaluate the relationship between visceral fat, fatty liver and asymptomatic coronary atherosclerosis in patients with the major cardiovascular risk factors and with or without metabolic syndrome.

Methods: 50 patients (age 53±7) with excess of visceral fat visceral, 30 patients with NAFLD and 30 sex, age matched individuals without NAFLD will be recruited . All will be asymptomatic for cardiac related symptoms. Subjects with clinical history of ischemic heart disease, cerebrovascular disease, renal failure, cancer and allergy to lode will be excluded. Coronary artery disease (CAD) will be defined as coronary plaques, with obstructive (70%) or non obstructive lesions (30%). Degree of fatty infiltration (ultrasound), Visceral fat amount (CT), coronary plaques and stenosis (coronary computed tomography angiography,CCTA), markers of insulin resistance,lipotoxicity, systemic inflammation, and oxidant-antioxidant status will be measured measured.

Expected Results: Patients with excess of visceral fat and patients with NAFLD will have higher prevalence of coronary plaques and higher prevalence of non obstructive coronary stenosis, higher HOMA CRP, and TG serum levels than controls. In patients with excess of visceral fat , more segments with atherosclerosis per patient will be detected . Multiple regression analysis is expected to show that visceral fat and fatty liver are strong predictors of coronary atherosclerosis independently by metabolic syndrome diagnosis and independently by markers of insulin resistance, lipotoxicity and inflammation.

Conclusion: Patients with excess of visceral fat and NAFLD patients will have higher prevalence of coronary atherosclerosis plaques independently by metabolic syndrome diagnosis. Suggesting that the presence of visceral fat and/or fatty liver will be considered an important condition to optimize the cardiovascular risk stratification.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

50 patients (age 53±7) with excess of visceral fat visceral, 30 patients with NAFLD and 30 sex, age matched individuals without NAFLD will be recruited

  • Visceral Fat
  • Fatty Liver
  • Atherosclerosis
  • Coronary Computed Tomography Angiography
  • Procedure: excess of visceral fat
    excess of visceral fat
  • Procedure: patients with NAFLD
    patients with NAFLD
  • patients with NAFLD
    Intervention: Procedure: patients with NAFLD
  • excess of visceral fat
    Intervention: Procedure: excess of visceral fat
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
150
December 2010
November 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • excess of visceral fat with the major cardiovascular risk factors for coronary CT,
  • diagnosis of fatty liver defined by the presence of bright liver echo pattern, absence of alcohol use (<20g/day),
  • negative serology for hepatitis B or C diagnosis,
  • negative auto antibodies,
  • absence of history of another known liver disease,
  • 30 sex-age-matched individual with cardiovascular risk factors and without NAFLD and without visceral fat will be considered as controls.
  • Informed consent will be obtained from each individual and the study will be presented to the the local ethics committee.

Exclusion Criteria:

  • subjects with severe obesity (BMI>35),
  • recent history of acute illness,
  • clinical history of ischemic heart disease and cerebro vascular disease,
  • typical chest pain,
  • previous coronary artery disease,
  • conventional coronary angiography,
  • percutaneous interventions,
  • coronary by pass grafting,
  • renal failure,
  • cancer patients,
  • subjects who take drugs that induces hepatic steatosis ( corticosteroids, estrogens, methotrexate, amiodarone and others).
  • Exclusion criteria for coronary computed tomography angiography will included also the presence of multiple ectopic beats, atrial fibrillation, heart rate more than 75/min despite therapy, severe lung disease, or a history of allergic reaction to iodine-containing contrast agents.
Both
40 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01282892
0052-08
No
Liver Clinic, Ziv medical center
Ziv Hospital
Not Provided
Not Provided
Ziv Hospital
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP