Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Launched by FONDAZIONE EPATOCENTRO TICINO · Jun 26, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on studying people with a condition called nonalcoholic fatty liver disease (NAFLD) and related liver problems, including NASH and MAFLD. The main goal is to gather detailed health information from these patients over time to better understand how the disease develops, how patients respond to treatments, and what factors like genetics or metabolism might affect the condition. This information will help doctors and researchers find better ways to diagnose, treat, and manage liver disease in the future.

Adults aged 18 and older who have been diagnosed with NAFLD or related conditions through liver tests or imaging, and who do not drink much alcohol, may be eligible to join the study. Patients with certain other liver diseases, type 1 diabetes, or who are pregnant or breastfeeding cannot participate. If you join, you will be asked to sign a consent form and complete some visits and tests to collect health information. This study doesn’t involve new treatments but focuses on collecting important data to improve care for people with fatty liver disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be ≥ 18 years of age at the time of signing the informed consent
• • 2. Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
• 3. To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:
• • 1. Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
• • 2. Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
• 3. Diagnosis of metabolic syndrome and liver fibrosis or cirrhosis without an alternative diagnosis; metabolic syndrome fulfilling one or more of the below mentioned conditions:
• • Abdominal obesity: a waist circumference of more than 35 inches (\>89cm) for women and more than 40 inches (\>102 cm) for men;
• • High blood pressure of 130/80 mm Hg or higher. Normal blood pressure is defined as less than 130 mm Hg for systolic pressure, and less than 80 mm Hg for diastolic pressure
• • Impaired fasting blood glucose. This means a level equal to or greater than 100 mg/dL (\>5.6 mmol/L)
• • High triglyceride levels of more than 150 mg/dL (\> 1.7mmol/L).
• • Low HDL (good) cholesterol: less than 40 mg/dL (\< 1.04 mmol/L) for men and less than 50 mg/dL (\< 1.29 mmol/L) for women
• • 4. alcohol consumption less than 21 (males) or 14 (women) units per week in the 6 months before the enrolment and no history of excessive alcohol consumption in the 5 years before enrolment. One unit is 12g (grams) of pure alcohol; 10-12 grams of pure alcohol are contained in a 280-330 ml of beer, 150-180 ml of champagne, 30-40 ml of whisky or high-strength spirit, 60-80 ml of liqueur, and 100-120 ml of red wine
• Exclusion Criteria:
• • 1. To have a diagnosis of type I diabetes mellitus
• • 2. To have a concomitant liver disease
• • 3. To take or have taken in the last 12 months before enrolment, on more than 50% of days, drugs that may cause liver steatosis (long-term high dose systemic corticosteroids (\> 20mg prednisone equivalent), amiodarone, methotrexate, tamoxifen, tetracycline, high dose estrogens and valproic acid)
• • 4. Pregnancy and breast feeding.