Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Recruiting

• Conditions: NAFLD; MASH; NASH/MASH

• Registration Number: NCT07051863
• Lead Sponsor: Fondazione Epatocentro Ticino

Brief Summary

The goal of this observational study is to establish a unified cohort for retrospective and prospective high quality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria.

This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-19
• Study First Submitted: 2025-06-26
• Study First Submitted QC: 2025-06-26
• Status Verified: 2025-07
• Study First Posted: 2025-07-04
• Last Update Submitted: 2025-07-04
• Last Update Posted: 2025-07-09
• Primary Completion: 2030-12
• Study Completion: 2030-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD	7 years	The primary objective of this project is to establish a unified cohort for retrospective and prospective highquality baseline and follow-up data registration of patients with a diagnosis of NAFLD/NASH/MAFLD, according to standardized criteria.; This will allow future studies aimed at elucidate clinical presentation, natural history, response to treatment, genetic and metabolic risk factors, treatment options and outcomes of the disease. The cohort will allow investigators to carry out genetic, serological, microbiologic and immunological studies.

Trial Locations

Locations (1)

Fondazione Epatocentro Ticino; 🇨🇭 Lugano, Ticino, Switzerland