Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver

Completed

• Conditions: Fatty Liver

• Registration Number: NCT02669316
• Lead Sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

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.

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-01-18
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-02-01
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	through study completion, an average of 4 years	left ventricular mass indexed by body surface area g/m2.

Secondary Outcome Measures

Name	Time	Method
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.	through study completion, an average of 4 years	Doppler transmitral E/A ratio
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.	through study completion, an average of 4 years	ejection fraction (%)

Trial Locations

Locations (1)

Guglielmo Trovato; 🇮🇹 Catania, CT, Italy