Liver Damage and Cardiometabolic Disorders in NAFLD
Recruiting · NCT04036357 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Roma La Sapienza
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
18 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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 is running
1 location listed.
- Day Service of Internal Medicine and Metabolic Disorders - Policlinico Umberto I - Sapienza University of Rome - Rome, Italy