NCT04036357Recruiting
Liver Damage and Cardiometabolic Disorders in NAFLD
Progression of LIver Damage and Cardiometabolic Disorders in Non-alcoholic Fatty Liver dIsease: an Observational Cohort STUDY. The Plinio Study
Source: ClinicalTrials.gov · Last updated 16 Aug 2019 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 25 Jul 2019
- Start date
- 1 Nov 2011
- Primary completion date
- 31 Dec 2036
- Lead sponsor
- University of Roma La Sapienza
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04036357
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 1 Nov 2011 to the primary completion date, 31 Dec 2036
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- concomitant therapy with drugs known to promote liver steatosis (e.g. amiodarone);
Other illness
- 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
- other chronic infectious or autoimmune disease;
Who the study is looking for
- Patients aged 18 years old or more
- Patients with at least on of the following metabolic disorders
- Obesity
- Diabetes
- Arterial hypertension
- Dyslipidemia
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome Coordinator of this site? Confirm its status | Rome | Italy | Recruiting |
Related publications
- Neutrophil cathepsin G and risk of cardiovascular events in patients with diabetes mellitus.Cardiovasc Diabetol · 2025 · PMID 41299502
- Platelet Thromboxane B2 overproduction associated with liver fibrosis severity in patients with MASLD.Thromb Res · 2026 · PMID 41273899
This page is information, not medical advice. Discuss any trial with your doctor.