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

NCT ID: NCT02669316

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

660 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Fatty Liver

Keywords

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diet

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele

OTHER

Sponsor Role lead

Responsible Party

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Guglielmo Trovato, MD, PhD

Dirigente Medico

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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GUGLIELMO TROVATO, MD

Role: PRINCIPAL_INVESTIGATOR

University of Catania - Policlinico

Locations

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Guglielmo Trovato

Catania, CT, Italy

Site Status

Countries

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Italy

Other Identifiers

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CARDIONAFLD

Identifier Type: -

Identifier Source: org_study_id