NCT04036357 Liver Damage and Cardiometabolic Disorders in NAFLD
| NCT ID | NCT04036357 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Roma La Sapienza |
| Condition | NAFLD |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,000 participants |
| Start Date | 2011-11 |
| Primary Completion | 2036-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,000 participants in total. It began in 2011-11 with a primary completion date of 2036-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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;
Contact & Investigator
Maria Del Ben, MD
STUDY DIRECTOR
University of Roma La Sapienza
Frequently Asked Questions
Who can join the NCT04036357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying NAFLD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04036357 currently recruiting?
Yes, NCT04036357 is actively recruiting participants. Contact the research team at francesco.baratta@uniroma1.it for enrollment information.
Where is the NCT04036357 trial being conducted?
This trial is being conducted at Rome, Italy.
Who is sponsoring the NCT04036357 clinical trial?
NCT04036357 is sponsored by University of Roma La Sapienza. The principal investigator is Maria Del Ben, MD at University of Roma La Sapienza. The trial plans to enroll 2,000 participants.