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
  Purpose

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


Condition Intervention
Visceral Fat
Fatty Liver
Atherosclerosis
Coronary Computed Tomography Angiography
Procedure: excess of visceral fat
Procedure: patients with NAFLD

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis

Resource links provided by NLM:


Further study details as provided by Ziv Hospital:

Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: December 2010
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
patients with NAFLD Procedure: patients with NAFLD
patients with NAFLD
excess of visceral fat Procedure: excess of visceral fat
excess of visceral fat

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01282892

Locations
Israel
Liver clinic
Safed, Israel, 13100
Ziv medical center liver unit
Safed, Israel, Israel
Sponsors and Collaborators
Ziv Hospital
  More Information

No publications provided

Responsible Party: Liver Clinic, Ziv medical center
ClinicalTrials.gov Identifier: NCT01282892     History of Changes
Other Study ID Numbers: 0052-08
Study First Received: January 18, 2011
Last Updated: January 24, 2011
Health Authority: Israel: Ministry of Health

Keywords provided by Ziv Hospital:
Visceral fat
fatty liver
atherosclerosis
coronary computed tomography angiography

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Coronary Artery Disease
Fatty Liver
Liver Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Coronary Disease
Digestive System Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014