Fact CheckerSign in

NCT07051863Recruiting

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease

Prospective Cohort and Biobank of Patients With Nonalcoholic Fatty Liver Disease (NAFLD Cohort Study)

Source: ClinicalTrials.gov · Last updated 21 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
300 (estimated)
First submitted
26 Jun 2025
Start date
Jul 2023
Primary completion date
Dec 2030
Lead sponsor
Fondazione Epatocentro Ticino
NCT number
NCT07051863

What you commit to

  • Study type: Observational
  • Planned participants: 300
  • From Jul 2023 to the primary completion date, Dec 2030
  • 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

  • To have a concomitant liver disease
  • 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)

Other illness

  • To have a diagnosis of type I diabetes mellitus

Other

  • Pregnancy and breast feeding.

Who the study is looking for

  • Participant must be ≥ 18 years of age at the time of signing the informed consent
  • Participant willing to sign the informed consent form (ICF) and to complete all study-specific procedures and visits
  • To have a diagnosis of NAFLD/NASH/MAFLD followed at Epatocentro Ticino and collaborating/referring clinicians based on:
    • Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
    • Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
    • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Fondazione Epatocentro Ticino
Coordinator of this site? Confirm its status
LuganoSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.