NCT02669316

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

Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 660 (actual)
• Sponsor: Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fatty Liver

Timeline

• Start date: 2008-01-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2016-02-01
• Last updated: 2016-03-31

Locations

1 site across 1 country: Italy