NAFLDPLINIONCT04036357
Liver Damage and Cardiometabolic Disorders in NAFLD
An observational study of NAFLD and Liver Fibroses, run by University of Roma La Sapienza at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- NAFLD, Liver Fibroses, Cardiovascular Diseases
- How many people
- 2,000 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2011to 31 Dec 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- Patients aged 18 years old or more
- Patients with at least on of the following metabolic disorders
- Obesity
- Diabetes
- Arterial hypertension
- Dyslipidemia
Who cannot join
- 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;
- diagnosis of oncological diseases
- concomitant therapy with drugs known to promote liver steatosis (e.g. amiodarone);
- other chronic infectious or autoimmune disease;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome
Rome, 00100
Maria Del Ben, MD, +390649972249, maria.delben@uniroma1.it
Francesco Baratta, MD, +390649972249, francesco.baratta@uniroma1.it
About this study
Official title: Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study
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.
Read the detailed description
Non-alcoholic fatty liver disease (NAFLD) is a common liver disease worldwide. NAFLD includes a spectrum of diseases raging from simple steatosis to non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma.
The prevalence of NAFLD ranges from 20% in the general population to 80-90% in obese and/or diabetic patients. Type 2 diabetes is also associated with disease progression. Some genetic conditions are known to be related with NAFLD pathophysiology. Mutation of patatin like phospholipase domain containing 3 (PNPLA3) is the most frequent genetic disorder associated with NAFLD onset and its accelerated progression. Both type 2 diabetes and PNPL3 mutation are the better-known factors associated with liver fibrosis.
More than the amount of lipid accumulation in the hepatocytes or of liver inflammation, the most important prognostic factors in NAFLD is fibrosis, which can occur in all stage of NAFLD disease, also in simple steatosis without inflammation or ballooning. Advanced fibrosis (F stage ≥ 3) has been related not only with liver-related death but also with death from all causes.
In 2007 a noninvasive system, the NAFLD fibrosis score (NFS), was validated to identify NAFLD patients with advanced fibrosis. NFS ≥ 0.676 detects an advanced fibrosis (F3-F4) with a positive predictive value of 90%-82% while NFS ≤ -1.455 excludes advanced fibrosis with a negative predictive value of 93%-88%.
In addition, in different settings, a score named Fibrosis-4 (FIB-4) was also validated to detect advanced fibrosis in patients with hepatitis B virus and hepatitis C virus /human immunodeficiency virus coinfection. Fib-4 ≤ 1.45 excludes advanced fibrosis with a negative predictive value of 90%, while Fib-4 ≥ 3.25 detects advanced fibrosis with a positive predictive value of 65%.
Currently, little is known about biochemical and pharmacological factors predicting liver fibrosis evolution in large cohorts of NAFLD patients.
Therefore, the primary aim of the study Is to investigate biochemical and pharmacological factors associated with fibrosis progression, identified as variations in noninvasive fibrosis scores, in a large population of patients with ultrasonography diagnosis of fatty liver disease.
A growing number of evidences show a higher cardiovascular risk in patients with NAFLD. Most of the data are derived from diabetic patients and there are not data derived from ad hoc studies. In addition, there are only few data on factors predicting incident cardiovascular (CV) events in patients with NAFLD.
Therefore, the secondary objective of the study is to investigate the association between NAFLD and CV events and to detect factors predicting CV events inception.
- Keywords
- NAFLD, Liver fibrosis, Cardiovascular
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Liver Cirrhosis, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Patients will be followed for an expected mean time of 120 months
Secondary outcomes (13)
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
Measured: Patients will be followed for an expected mean time of 60 months
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.
Measured: At Baseline
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
Measured: At Baseline
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
Measured: Patients will be followed for an expected mean time of 120 months
Factors associated with chronic kidney disease in NAFLD patients
To investigate the prevalence of chronic renal failure in Patients with NAFLD. Moreover, genetic, pharmacological and biochemical factors associated with estimated glomerular filtration rate (eGFR) < 90 and with eGFR < 60 will be investigated.
Measured: At Baseline
Predictors of kidney disease progression in patients with NAFLD
The rate of Kidney disease progression in patients with NAFLD will be measured and will and compared to that in general populations. Predictors of kidney disease progression will be investigated.
Measured: Patients will be followed for an expected mean time of 60 months
Role of gut microbiota in NAFLD
Serum Lipopolysaccharide (LPS) and serum zonulin will be measured in NAFLD patients and the correlation between LPS and NAFLD severity will be tested
Measured: At Baseline
Echocardiographic changes in patients with NAFLD
Measures of systolic and diastolic function will be collected at baseline and correlated with the severity of NAFLD, of metabolic disorders and with genetic mutations correlated with NAFLD.
Measured: At Baseline
Score of cardiovascular risk in patients with NAFLD
Performance of classical scores of cardiovascular risk will be tested in patients of NAFLD. In particular, the 2MACE score and the Systemic Coronary Risk Estimation (SCORE) will be tested. 2MACE score will be calculated assigning 2 points for Metabolic Syndrome and Age ≥75, 1 point for MI/revascularization, Congestive heart failure (ejection fraction ≤40 %), thrombo-Embolism (stroke/transient ischemic attack. The score, ranging from 0 to 7 points, will be considered positive for values higher than 2. SCORE will be calculated using age, sex, systolic blood pressure, smoking status, total and HDL cholesterol. The SCORE system estimates the 10-year cumulative risk of a first fatal atherosclerotic event. In absence of a good performance of pre-existing scores, we'll try to assess a specific cardiovascular risk score in NAFLD patients.
Measured: Patients will be followed for an expected mean time of 120 months
Dyslipidemia and cardiovascular events in patients with NAFLD
The predictive role of triglycerides rich lipoproteins and cholesterol remnants will be evaluated.
Measured: Patients will be followed for an expected mean time of 120 months
Plasmatic and urinary isoprostanes
Plasmatic and urinary isoprostanes will be measured as markers of systemic oxidative stress and of antioxidant status in NAFLD and NASH. Differences of these markers in different degree of NAFLD severity will be investigated
Measured: At Baseline
Reactive species of oxygen in NAFLD and NASH
Reactive species of oxygen will be measured as markers of systemic oxidative stress and of antioxidant status in NAFLD and NASH. Differences of these markers in different degree of NAFLD severity will be investigated
Measured: At Baseline
Nadph oxidase (nox2) activation in NAFLD and NASH
Nadph oxidase (nox2) activation will be estimated as markers of systemic oxidative stress and of antioxidant status in NAFLD and NASH. Differences of these markers in different degree of NAFLD severity will be investigated
Measured: At Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study startNov 2011
- Primary completion31 Dec 2036 (estimated)
- Study completion31 Dec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for NAFLDStudies of the same condition, open and under way.
- More trials run by University of Roma La SapienzaThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roma La Sapienza
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francesco Violi, University of Roma La Sapienza
- Investigators
- Maria Del Ben, MD, Study director, University of Roma La SapienzaDaniele Pastori, MD, Principal investigator, University of Roma La SapienzaFrancesco Baratta, MD, Principal investigator, University of Roma La SapienzaFrancesco Angelico, MD, Principal investigator, University of Roma La Sapienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036357
- Sponsor's protocol ID
- 2277/2011
- Acronym
- PLINIO
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Baratta F, Bartimoccia S, Pastori D, Cocomello N, Cammisotto V, Castellani V, Nocella C, Forte M, Picchio V, Carnevale R, Desideri G, Pignatelli P, Violi F. Neutrophil cathepsin G and risk of cardiovascular events in patients with diabetes mellitus. Cardiovasc Diabetol. 2025 Nov 26;24(1):448. doi: 10.1186/s12933-025-03005-y.
PubMed 41299502Baratta F, Cocomello N, Carpino G, Colantoni A, Cammisotto V, Bartimoccia S, Castellani V, Overi D, Lucatelli P, Ettorre E, Carnevale R, Pignatelli P, Pastori D, Del Ben M, Gaudio E, Desideri G, Violi F. Platelet Thromboxane B2 overproduction associated with liver fibrosis severity in patients with MASLD. Thromb Res. 2026 Jan;257:109540. doi: 10.1016/j.thromres.2025.109540. Epub 2025 Nov 15.
PubMed 41273899Baratta F, D'Erasmo L, Di Costanzo A, Umbro I, Pastori D, Angelico F, Del Ben M. Metabolic Syndrome but Not Fatty Liver-Associated Genetic Variants Correlates with Glomerular Renal Function Decline in Patients with Non-Alcoholic Fatty Liver Disease. Biomedicines. 2022 Mar 19;10(3):720. doi: 10.3390/biomedicines10030720.
PubMed 35327522Baratta F, Pastori D, Angelico F, Balla A, Paganini AM, Cocomello N, Ferro D, Violi F, Sanyal AJ, Del Ben M. Nonalcoholic Fatty Liver Disease and Fibrosis Associated With Increased Risk of Cardiovascular Events in a Prospective Study. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2324-2331.e4. doi: 10.1016/j.cgh.2019.12.026. Epub 2019 Dec 27.
PubMed 31887443
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study
- ClinicalTrials.gov ID
- NCT04036357
- Acronym / sponsor ID
- PLINIO / 2277/2011
- Keywords
- NAFLD, Liver fibrosis, Cardiovascular
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University of Roma La SapienzaUniversity, hospital or other
- Study start
- Nov 2011 (actual)
- Primary completion
- 31 Dec 2036 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 29 Jul 2019 (actual)
- 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.
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.
Detailed description
Non-alcoholic fatty liver disease (NAFLD) is a common liver disease worldwide. NAFLD includes a spectrum of diseases raging from simple steatosis to non-alcoholic steatohepatitis (NASH), cirrhosis and hepatocellular carcinoma.
The prevalence of NAFLD ranges from 20% in the general population to 80-90% in obese and/or diabetic patients. Type 2 diabetes is also associated with disease progression. Some genetic conditions are known to be related with NAFLD pathophysiology. Mutation of patatin like phospholipase domain containing 3 (PNPLA3) is the most frequent genetic disorder associated with NAFLD onset and its accelerated progression. Both type 2 diabetes and PNPL3 mutation are the better-known factors associated with liver fibrosis.
More than the amount of lipid accumulation in the hepatocytes or of liver inflammation, the most important prognostic factors in NAFLD is fibrosis, which can occur in all stage of NAFLD disease, also in simple steatosis without inflammation or ballooning. Advanced fibrosis (F stage ≥ 3) has been related not only with liver-related death but also with death from all causes.
In 2007 a noninvasive system, the NAFLD fibrosis score (NFS), was validated to identify NAFLD patients with advanced fibrosis. NFS ≥ 0.676 detects an advanced fibrosis (F3-F4) with a positive predictive value of 90%-82% while NFS ≤ -1.455 excludes advanced fibrosis with a negative predictive value of 93%-88%.
In addition, in different settings, a score named Fibrosis-4 (FIB-4) was also validated to detect advanced fibrosis in patients with hepatitis B virus and hepatitis C virus /human immunodeficiency virus coinfection. Fib-4 ≤ 1.45 excludes advanced fibrosis with a negative predictive value of 90%, while Fib-4 ≥ 3.25 detects advanced fibrosis with a positive predictive value of 65%.
Currently, little is known about biochemical and pharmacological factors predicting liver fibrosis evolution in large cohorts of NAFLD patients.
Therefore, the primary aim of the study Is to investigate biochemical and pharmacological factors associated with fibrosis progression, identified as variations in noninvasive fibrosis scores, in a large population of patients with ultrasonography diagnosis of fatty liver disease.
A growing number of evidences show a higher cardiovascular risk in patients with NAFLD. Most of the data are derived from diabetic patients and there are not data derived from ad hoc studies. In addition, there are only few data on factors predicting incident cardiovascular (CV) events in patients with NAFLD.
Therefore, the secondary objective of the study is to investigate the association between NAFLD and CV events and to detect factors predicting CV events inception.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (6 listed)
- Patients aged 18 years old or more
- Patients with at least on of the following metabolic disorders
Key exclusion criteria (7 listed)
- 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;
- diagnosis of oncological diseases
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
Clinical, biochemical and genetic factors associated to progression of liver fibrosis in a large cohort of patients with NAFLD
Time frame: Patients will be followed for an expected mean time of 120 months
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.
13 secondary outcomes
The predictive role of non-invasive markers of fibrosis on the incidence of major cardiovascular events.
Time frame: Patients will be followed for an expected mean time of 60 months
Nutritional factors associated to NAFLD
Time frame: At Baseline
Platelet activation in NAFLD and NASH
Time frame: At Baseline
The predictive role of systemic markers of oxidative stress and antioxidant status on the incidence of cardiovascular events in NAFLD patients
Time frame: Patients will be followed for an expected mean time of 120 months
Factors associated with chronic kidney disease in NAFLD patients
Time frame: At Baseline
Predictors of kidney disease progression in patients with NAFLD
Time frame: Patients will be followed for an expected mean time of 60 months
Role of gut microbiota in NAFLD
Time frame: At Baseline
Echocardiographic changes in patients with NAFLD
Time frame: At Baseline
Score of cardiovascular risk in patients with NAFLD
Time frame: Patients will be followed for an expected mean time of 120 months
Dyslipidemia and cardiovascular events in patients with NAFLD
Time frame: Patients will be followed for an expected mean time of 120 months
Plasmatic and urinary isoprostanes
Time frame: At Baseline
Reactive species of oxygen in NAFLD and NASH
Time frame: At Baseline
Nadph oxidase (nox2) activation in NAFLD and NASH
Time frame: At Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
- Derived from this study: PubMed 41299502Baratta F, Bartimoccia S, Pastori D, Cocomello N, Cammisotto V, Castellani V, Nocella C, Forte M, Picchio V, Carnevale R, Desideri G, Pignatelli P, Violi F. Neutrophil cathepsin G and risk of cardiovascular events in patients with diabetes mellitus. Cardiovasc Diabetol. 2025 Nov 26;24(1):448. doi: 10.1186/s12933-025-03005-y.
- Derived from this study: PubMed 41273899Baratta F, Cocomello N, Carpino G, Colantoni A, Cammisotto V, Bartimoccia S, Castellani V, Overi D, Lucatelli P, Ettorre E, Carnevale R, Pignatelli P, Pastori D, Del Ben M, Gaudio E, Desideri G, Violi F. Platelet Thromboxane B2 overproduction associated with liver fibrosis severity in patients with MASLD. Thromb Res. 2026 Jan;257:109540. doi: 10.1016/j.thromres.2025.109540. Epub 2025 Nov 15.
- Derived from this study: PubMed 35327522Baratta F, D'Erasmo L, Di Costanzo A, Umbro I, Pastori D, Angelico F, Del Ben M. Metabolic Syndrome but Not Fatty Liver-Associated Genetic Variants Correlates with Glomerular Renal Function Decline in Patients with Non-Alcoholic Fatty Liver Disease. Biomedicines. 2022 Mar 19;10(3):720. doi: 10.3390/biomedicines10030720.
- Derived from this study: PubMed 31887443Baratta F, Pastori D, Angelico F, Balla A, Paganini AM, Cocomello N, Ferro D, Violi F, Sanyal AJ, Del Ben M. Nonalcoholic Fatty Liver Disease and Fibrosis Associated With Increased Risk of Cardiovascular Events in a Prospective Study. Clin Gastroenterol Hepatol. 2020 Sep;18(10):2324-2331.e4. doi: 10.1016/j.cgh.2019.12.026. Epub 2019 Dec 27.
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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.
Maria Del Ben, MD study director
University of Roma La Sapienza
Daniele Pastori, MD principal investigator
University of Roma La Sapienza
Francesco Baratta, MD principal investigator
University of Roma La Sapienza
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 NAFLD and Liver Fibroses, run by University of Roma La Sapienza 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 6 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 16 Aug 2019. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Baratta, MD, PI. (+390649972249, francesco.baratta@uniroma1.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical, biochemical and genetic factors associated to progression of liver fibrosis in a large cohort of patients with NAFLD (time frame: Patients will be followed for an expected mean time of 120 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04036357, which also lists 4 linked publications.
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 16 Aug 2019.