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

Sponsor
Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele (Other)
Overall Status
Completed
CT.gov ID
NCT02669316
Collaborator
(none)
660
Enrollment
1
Location
95
Duration (Months)
6.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    660 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
    Study Start Date :
    Jan 1, 2008
    Actual Primary Completion Date :
    Dec 1, 2015
    Actual Study Completion Date :
    Dec 1, 2015

    Outcome Measures

    Primary Outcome Measures

    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. [through study completion, an average of 4 years]

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

    Secondary Outcome Measures

    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. [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. [through study completion, an average of 4 years]

      ejection fraction (%)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guglielmo Trovato Catania CT Italy 95131

    Sponsors and Collaborators

    • Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

    Investigators

    • Principal Investigator: GUGLIELMO TROVATO, MD, University of Catania - Policlinico

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guglielmo Trovato, MD, PhD, Dirigente Medico, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
    ClinicalTrials.gov Identifier:
    NCT02669316
    Other Study ID Numbers:
    • CARDIONAFLD
    First Posted:
    Feb 1, 2016
    Last Update Posted:
    Mar 31, 2016
    Last Verified:
    Mar 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Guglielmo Trovato, MD, PhD, Dirigente Medico, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
    diet
    Additional relevant MeSH terms:
    Fatty Liver

    Study Results

    No Results Posted as of Mar 31, 2016