Overview

This trial is active, not recruiting.

Conditions visceral fat, fatty liver, atherosclerosis, coronary computed tomography angiography
Treatments excess of visceral fat, patients with nafld
Sponsor Ziv Hospital
Start date February 2009
End date November 2009
Trial size 150 participants
Trial identifier NCT01282892, 0052-08

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
patients with nafld
patients with NAFLD
excess of visceral fat
excess of visceral fat

Eligibility Criteria

Male or female participants from 40 years up to 70 years old.

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.

Additional Information

Official title Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by Ziv Hospital.