Actively Recruiting

Age: 18Years - 80Years
All Genders
ID04036357

Progression of Liver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver Disease: an Observational Cohort Study The Plinio Study

Led by University of Roma La Sapienza · Updated on 2019-08-16

2000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to investigate factors related to liver fibrosis progression and cardiovascular risks in people with non-alcoholic fatty liver disease (NAFLD). NAFLD is a common liver condition ranging from simple fat buildup to severe liver damage including cirrhosis and cancer. The study focuses on understanding how biochemical and genetic factors, alongside known conditions like diabetes and specific gene mutations, influence fibrosis evolution and cardiovascular events in a large group of patients with fatty liver disease diagnosed by ultrasound. Participants will not receive treatments as this is an observational study. Researchers will track fibrosis progression using noninvasive scores such as NAFLD fibrosis score and Fibrosis-4 over an average of 10 years. The study will also explore the relationship between NAFLD and cardiovascular events, looking at various biochemical markers, nutritional factors, and genetic influences at baseline and during follow-up. Secondary outcomes include evaluating kidney disease progression and cardiovascular risk scores. During the study, participants will undergo regular clinical, biochemical, and genetic evaluations. Assessments will include measurements of liver fibrosis progression, cardiovascular risk, oxidative stress markers, and gut microbiota analysis. Follow-up is expected to last around 10 years for fibrosis progression and cardiovascular outcomes, with some measures assessed at baseline. The study will monitor health outcomes without intervention to better understand the natural course of NAFLD and related disorders.

CONDITIONS

Brief Title

Liver Damage and Cardiometabolic Disorders in NAFLD

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Patients with at least one metabolic disorder such as obesity, diabetes, high blood pressure, or abnormal blood fats
Not Eligible

You will not qualify if you...

  • Average daily alcohol consumption over 20 g in women or over 30 g in men
  • Presence of hepatitis B surface antigen or hepatitis C virus antibody
  • Positive tests for autoimmune hepatitis
  • Cirrhosis or other chronic liver diseases
  • Diagnosis of cancer
  • Current treatment with drugs known to promote liver fat accumulation (e.g., amiodarone)
  • Other chronic infectious or autoimmune diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Long-term Monitoring

Duration - Up to 120 months

Participants are observed over time to study the progression of liver fibrosis and the occurrence of cardiovascular events in NAFLD.

Periodic visits over the follow-up period

Trial Site Locations

Total: 1 location

1

Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome

Rome, Italy, 00100

Actively Recruiting

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Research Team

F

Francesco Baratta, MD, PI.

D

Daniele Pastori, MD, PI.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Metabolic Syndrome but Not Fatty Liver-Associated Genetic Variants Correlates with Glomerular Renal Function Decline in Patients with Non-Alcoholic Fatty Liver Disease.

Francesco Baratta, Laura D'Erasmo, Alessia Di Costanzo...

https://pubmed.ncbi.nlm.nih.gov/35327522

Nonalcoholic Fatty Liver Disease and Fibrosis Associated With Increased Risk of Cardiovascular Events in a Prospective Study.

Francesco Baratta, Daniele Pastori, Francesco Angelico...

https://pubmed.ncbi.nlm.nih.gov/31887443