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Completed

NCT Number: NCT02669316

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

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.

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Key information

Conditions

Fatty Liver Digestive System Diseases Liver Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guglielmo Trovato

Catania, CT, 95131, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 4 years

    left ventricular mass indexed by body surface area g/m2.

Secondary outcomes

  1. 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.

    Time frame: through study completion, an average of 4 years

    Doppler transmitral E/A ratio

  2. 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.

    Time frame: through study completion, an average of 4 years

    ejection fraction (%)

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

Other

Registry information

Official study title

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

Acronym: CARDIONAFLD

Important dates

Study start
2008
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2016
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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