Fatty liver disease: a new biobank aims to unlock the secrets of a silent epidemic

NCT ID NCT07051863

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study creates a large database and biobank of people with nonalcoholic fatty liver disease (NAFLD), a condition where fat builds up in the liver. Researchers will collect medical data and biological samples over time to study how the disease develops, progresses, and responds to treatments. The goal is to enable future studies that could lead to better diagnosis and care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this biobank could help researchers identify new risk factors, biomarkers, and potential treatments for fatty liver disease.
What could go wrong
This is an observational study, not a treatment trial. It collects data for future research, so it will not directly test any new therapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2023

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patient wiht diagnosis of NAFLD/NASH/MAFLD

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Epatocentro Ticino

    RECRUITING

    Lugano, Canton Ticino, 6900, Switzerland

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