About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Liver biopsy with a histological evidence of NAFLD/NASH/MAFLD OR
Liver imaging (ultrasound, CT scan, MRI, CAP Controlled Attenuation Parameter) OR
Disqualifiers
To have a diagnosis of type I diabetes mellitus
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)
Pregnancy and breast feeding.
Trial population
Patient wiht diagnosis of NAFLD/NASH/MAFLD
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Establish a unified cohort for retrospective and prospective data of patients with a diagnosis of NAFLD/NASH/MAFLD
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.
Sponsors and contacts
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