Liver Damage and Cardiometabolic Disorders in NAFLD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorUniversity of Roma La Sapienza
About this trial
Liver fibrosis is the most important prognostic factor in patients with non-alcoholic factor disease. Clinical and biological condition, as diabetes or mutation for PNPLA3, are well known factors associated with liver fibrosis onset and progression. However, little is known about biochemical factors predicting liver fibrosis evolution in large NAFLD populations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years old or more
Patients with at least on of the following metabolic disorders
Obesity
Diabetes
Disqualifiers
Average daily consumption of alcohol >20 g in women and of >30 g in men (assessed by Alcohol Use Disorders Identification Test, AUDIT;
presence of hepatitis B surface antigen and antibody to hepatitis C virus;
positive tests for autoimmune hepatitis;
cirrhosis and other chronic liver diseases;
Trial population
Consecutive outpatients referring to the Day Service of Internal Medicine and Metabolic Diseases of the Department of Internal Medicine of Sapienza University of Rome for the management of cardio-metabolic risk factors, such as metabolic syndrome, dyslipidemia, hypertension, diabetes.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Clinical, biochemical and genetic factors associated to progression of liver fibrosis in a large cohort of patients with NAFLD
To detect non conventional factors associated with the progression of liver fibrosis in patients with NAFLD. Progression of liver fibrosis will be assessed by non invasive markers (such as FIB-4, Nafld Fibrosis Score e liver elastography). The predictive role of the following factors will be assessed: plasmatic and urinary isoprostanes, thromboxane, platelet recruitment, reactive species of oxygen, nadph oxidase (nox2). Genes of interested will be sequenced.
Time frame
Patients will be followed for an expected mean time of 120 monthsSecondary outcomes
1
The predictive role of non-invasive markers of fibrosis on the incidence of major cardiovascular events.
Non invasive score of liver fibrosis (such as NAFLD fibrosis score, AST-to-Platelets index and FIB-4) will be calculated at baseline and their predictive role on the incidence of major cardiovascular events will be tested
Time frame
Patients will be followed for an expected mean time of 60 months2
Nutritional factors associated to NAFLD
Data on mediterranean diet adherence and on nutrients consumption will be collected and related to NAFLD severity. Data on circulating free fatty acid will be collected.
Time frame
At Baseline3
Platelet activation in NAFLD and NASH
Plasmatic and urinary thromboxane and platelet recruitment will be measured as markers of platelets activation. Differences of these markers in different degree of NAFLD severity will be investigated
Time frame
At Baseline4
The predictive role of systemic markers of oxidative stress and antioxidant status on the incidence of cardiovascular events in NAFLD patients
Oxidative stress markers such as plasmatic and urinary isoprostanes, thromboxane, platelet recruitment, reactive species of oxygen, nadph oxidase(nox2) will be measured. The predictive role of these markers on the incidence of cardiovascular events will be tested
Time frame
Patients will be followed for an expected mean time of 120 monthsSponsors and contacts
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Source ClinicalTrials.gov