Fatty LiverCARDIONAFLDNCT02669316
Echocardiography, Adherence to Mediterranean Diet (AMDS) and Physical Exercise in Fatty Liver
An observational study of Fatty Liver, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver
- How many people
- 660 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2008to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Clinical diagnosis on fatty liver
Who cannot join
- Diabetes
- Cancer
- virus hepatitis
- alcohol habits above 20 g/day (140 g/week) and any binge drinking
- myocardial infarction,
- valvular or congenital heart disease
Show all 9Show fewer
- heart failure
- respiratory or renal insufficiency
- rheumatic or autoimmune disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Fatty Liver
- Keywords
- diet
- Medical subject headings
- Fatty Liver
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Doppler transmitral E/A ratio
Measured: 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.
ejection fraction (%)
Measured: through study completion, an average of 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guglielmo Trovato, MD, PhD, Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele
- Investigators
- GUGLIELMO TROVATO, MD, Principal investigator, University of Catania - Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669316
- Sponsor's protocol ID
- CARDIONAFLD
- Acronym
- CARDIONAFLD
- Status last verified
- Mar 2016
- First submitted
- 18 Jan 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence to Mediterranean Diet and Physical Exercise Profile in NAFLD: Relationship With Echocardiography Measures in Non-diabetic Subjects.
- ClinicalTrials.gov ID
- NCT02669316
- Acronym / sponsor ID
- CARDIONAFLD / CARDIONAFLD
- Conditions
- Fatty Liver
- Keywords
- diet
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Azienda Ospedaliera, Universitaria Policlinico Vittorio EmanueleUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Clinical diagnosis on fatty liver
Key exclusion criteria (9 listed)
- Diabetes
- Cancer
- virus hepatitis
- alcohol habits above 20 g/day (140 g/week) and any binge drinking
- myocardial infarction,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GUGLIELMO TROVATO, MD principal investigator
University of Catania - Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatty Liver, run by Azienda Ospedaliera, Universitaria Policlinico Vittorio Emanuele at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2016.