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

NCT ID: NCT01282892

Last Updated: 2011-01-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-12-31

Brief Summary

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

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.

Conditions

Visceral Fat; Fatty Liver; Atherosclerosis; Coronary Computed Tomography Angiography

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with NAFLD

patients with NAFLD

Intervention Type: PROCEDURE

patients with NAFLD

excess of visceral fat

excess of visceral fat

Intervention Type: PROCEDURE

excess of visceral fat

Interventions

excess of visceral fat

excess of visceral fat

Intervention Type: PROCEDURE

patients with NAFLD

patients with NAFLD

Intervention Type: PROCEDURE

Eligibility 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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ziv Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ziv medical center

Locations

Liver clinic

Safed, , Israel

Ziv medical center liver unit

Safed, Israel, , Israel

Countries

Israel

Other Identifiers

0052-08

Identifier Type: -

Identifier Source: org_study_id