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

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01282892
• Other study ID #: 0052-08
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2011
• Last updated: January 24, 2011
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: January 2011
• Source: Ziv Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Coronary Artery Disease
• Coronary Computed Tomography Angiography
• Fatty Liver
• Liver Diseases
• Myocardial Ischemia
• Visceral Fat

Intervention

Procedure:
• excess of visceral fat
excess of visceral fat
• patients with NAFLD
patients with NAFLD

Locations

Country	Name	City	State
Israel	Liver clinic	Safed
Israel	Ziv medical center liver unit	Safed, Israel

Sponsors (1)

Lead Sponsor	Collaborator
Ziv Hospital

Country where clinical trial is conducted

Israel,