Clinical trial Recruiting at 1 site Observational Ages 18 to 80

Understanding liver damage and heart health in patients with NAFLD

Official title: Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study

Run by University of Roma La Sapienza · NCT04036357 · Data updated 2026-11-12

This study looks at how liver damage affects heart health in people with non-alcoholic fatty liver disease to see what factors might predict worsening liver problems.

More Cardiovascular Diseases trials

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexAll
Enrollment2000 (estimated)
SponsorUniversity of Roma La Sapienza
Academic / other
Locations1 site (Rome)
StatusRecruiting
StartedNovember 2011
Main results expectedDecember 31, 2036
Study endsDecember 31, 2036
Registry record updatedAugust 16, 2019
Trial IDNCT04036357 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are adults aged 18 and older with metabolic disorders such as obesity, diabetes, arterial hypertension, or dyslipidemia.

Probably not a fit

Patients with significant alcohol consumption, chronic liver diseases, or other serious health conditions may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on non-alcoholic fatty liver disease (NAFLD), a common condition that can lead to serious liver and cardiovascular issues. It aims to identify biochemical factors that predict the progression of liver fibrosis in a large population of NAFLD patients, particularly those with metabolic disorders such as obesity and diabetes. The study will utilize established scoring systems like the NAFLD fibrosis score (NFS) to assess the severity of liver fibrosis and its implications for overall health. By analyzing these factors, the study seeks to enhance understanding of NAFLD's impact on liver and cardiovascular health.

Why it matters

Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for patients with NAFLD, potentially reducing liver-related and cardiovascular complications.

How similar studies have gone: Previous studies have shown success in identifying prognostic factors for liver fibrosis in NAFLD, making this approach both relevant and potentially impactful.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Patients aged 18 years old or more
* Patients with at least on of the following metabolic disorders

  * Obesity
  * Diabetes
  * Arterial hypertension
  * Dyslipidemia

Exclusion Criteria:

* 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;

Where it's running

  • Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome
    Rome, Italy
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.