Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver
CARDIONAFLD
Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
1 other identifier
observational
660
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 18, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedMarch 31, 2016
March 1, 2016
7.9 years
January 18, 2016
March 30, 2016
Conditions
Keywords
Outcome Measures
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.
left ventricular mass indexed by body surface area g/m2.
through study completion, an average of 4 years
Secondary Outcomes (2)
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
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
Eligibility Criteria
subjects withour acute or chronic disease checked by US imaging of the liver during routine work-up for dietary and physical exercise counseling
You may qualify if:
- Clinical diagnosis on fatty liver
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guglielmo Trovato
Catania, CT, 95131, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
GUGLIELMO TROVATO, MD
University of Catania - Policlinico
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dirigente Medico
Study Record Dates
First Submitted
January 18, 2016
First Posted
February 1, 2016
Study Start
January 1, 2008
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 31, 2016
Record last verified: 2016-03
Data Sharing
- IPD Sharing
- Will not share