Clinical trial NCT02669316: Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver
Official title: Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Keywords: diet
Lead sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Sponsor class: OTHER
First posted: 2016-02-01
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects withour acute or chronic disease checked by US imaging of the liver during routine work-up for dietary and physical exercise counseling

Brief summary: 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.

Detailed description: METHOD and measures: Age, obesity (BMI) , dietary profile (assessed as Adherence to Mediterranean Diet Score, AMDS), physical activity profile, assessed by the Baecke's physical exercise questionnaire, Insulin resistance (assessed by HOMA) were all taken into account for their confounding and synergic effect. Multiple regression analysis and Odds ratio will be the statistical tools that will be used.Receiver operator curve (ROC) analysis will be applied in order to find the cut-off, if any, of the considered measures vs. NAFLD and significant abnormalities of echocardiography measures.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: through study completion, an average of 4 years
Secondary outcomes:
measure: 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.
timeFrame: through study completion, an average of 4 years
measure: 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.
timeFrame: through study completion, an average of 4 years
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Guglielmo Trovato
state: CT
Study officials:
affiliation: University of Catania - Policlinico
name: GUGLIELMO TROVATO, MD
role: PRINCIPAL_INVESTIGATOR
References: