Understanding liver damage and heart health in patients with NAFLD
Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study
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.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University of Roma La Sapienza Academic / other |
| Locations | 1 site (Rome) |
| Trial ID | NCT04036357 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with metabolic disorders such as obesity, diabetes, arterial hypertension, or dyslipidemia.
Not a fit: Patients with significant alcohol consumption, chronic liver diseases, or other serious health conditions may not benefit from this study.
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 performed: Previous studies have shown success in identifying prognostic factors for liver fibrosis in NAFLD, making this approach both relevant and potentially impactful.
Eligibility criteria
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 this trial is running
Rome
- Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome — Rome, Italy (Recruiting)
Study contacts
- Principal investigator: Daniele Pastori, MD — University of Roma La Sapienza
- Study coordinator: Francesco Baratta, MD, PI.
- Email: francesco.baratta@uniroma1.it
- Phone: +390649972249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.