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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02669316

Acronym

CARDIONAFLD

Enrollment

660

Registered

2016-02-01

Start date

2008-01-31

Completion date

2015-12-31

Last updated

2016-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fatty Liver

Keywords

diet

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 (%)

Countries

Italy

Outcome results