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UnknownNCT01282892

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

Status
Unknown
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Ziv Hospital · Other Government
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Accepted

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

Interventions

TypeNameDescription
PROCEDUREexcess of visceral fatexcess of visceral fat
PROCEDUREpatients with NAFLDpatients with NAFLD

Timeline

Start date
2009-02-01
Primary completion
2009-11-01
Completion
2010-12-01
First posted
2011-01-25
Last updated
2011-01-25

Locations

2 sites across 1 country: Israel

Source: ClinicalTrials.gov record NCT01282892. Inclusion in this directory is not an endorsement.