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

A

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Status

Completed

Conditions

Fatty Liver

Study type

Observational

Funder types

Other

Identifiers

NCT02669316
CARDIONAFLD

Details and patient eligibility

About

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.

Full 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.

Enrollment

660 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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