- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02669316
Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver (CARDIONAFLD)
March 30, 2016 updated by: Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
660
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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CT
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Catania, CT, Italy, 95131
- Guglielmo Trovato
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
subjects withour acute or chronic disease checked by US imaging of the liver during routine work-up for dietary and physical exercise counseling
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
through study completion, an average of 4 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
Time Frame: through study completion, an average of 4 years
|
ejection fraction (%)
|
through study completion, an average of 4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: GUGLIELMO TROVATO, MD, University of Catania - Policlinico
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
January 18, 2016
First Submitted That Met QC Criteria
January 27, 2016
First Posted (Estimate)
February 1, 2016
Study Record Updates
Last Update Posted (Estimate)
March 31, 2016
Last Update Submitted That Met QC Criteria
March 30, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CARDIONAFLD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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