Visceral Abdominal Fat, Non Alcoholic Fatty Liver Diseases and Asymptomatic Coronary Atherosclerosis
1 other identifier
observational
150
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2009
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedFirst Submitted
Initial submission to the registry
January 18, 2011
CompletedFirst Posted
Study publicly available on registry
January 25, 2011
CompletedJanuary 25, 2011
January 1, 2011
9 months
January 18, 2011
January 24, 2011
Conditions
Keywords
Study Arms (2)
patients with NAFLD
excess of visceral fat
Interventions
Eligibility Criteria
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
You may qualify if:
- 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,
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ziv Hospitallead
Study Sites (2)
Liver clinic
Safed, 13100, Israel
Ziv medical center liver unit
Safed, Israel, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
January 18, 2011
First Posted
January 25, 2011
Study Start
February 1, 2009
Primary Completion
November 1, 2009
Study Completion
December 1, 2010
Last Updated
January 25, 2011
Record last verified: 2011-01