Fatty Liver Clinical Trial
— CARDIONAFLDOfficial title:
Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
NAFLD is associated with unhealthy lifestyle and obesity, without alcohol habits. An association of NAFLD with coronary artery disease and with impaired heart function was reported, but without considering severity of NAFLD and with the bias of including diabetes. Aim: to challenge if severity of liver steatosis assessed by UltraSound Bright Liver Score (BLS) can predict the impairment of systolic heart function, assessed by echocardiography (Ejection Fraction, EF), diastolic function (assessed by E/A ratio), Left Ventricular Mass, Left atrial diameter.
Status | Completed |
Enrollment | 660 |
Est. completion date | December 2015 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: Clinical diagnosis on fatty liver Exclusion Criteria: - Diabetes - Cancer - virus hepatitis - alcohol habits above 20 g/day (140 g/week) and any binge drinking - myocardial infarction, - valvular or congenital heart disease - heart failure - respiratory or renal insufficiency - rheumatic or autoimmune disease. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Italy | Guglielmo Trovato | Catania | CT |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Left Ventricular Myocardial mass: the measurement described below is echo-cardiographic, taken according to the joint guidelines of the American and European Societies of Echocardiography with appropriate equipments. | left ventricular mass indexed by body surface area g/m2. | through study completion, an average of 4 years | No |
Secondary | assessment of diastolic function: the measurement described below is echo-cardiographic, taken according to the joint guidelines of the American and European Societies of Echocardiography with appropriate equipments. | Doppler transmitral E/A ratio | through study completion, an average of 4 years | No |
Secondary | assessment of systolic function: the measurement described below is echo-cardiographic, taken according to the joint guidelines of the American and European Societies of Echocardiography with appropriate equipments. | ejection fraction (%) | through study completion, an average of 4 years | No |
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