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A smartphone app may help curb the silent march of fatty liver disease toward cirrhosis

NCT ID NCT06879236

Disease control Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial tests whether a mobile app called OpenTele can help people with fatty liver disease (MASLD) follow lifestyle changes like diet and exercise, which are currently the only treatments. The app guides patients daily and gives healthcare professionals a dashboard to monitor progress. Researchers will check if people use the app regularly and whether it leads to weight loss and improvements in liver stiffness over a year. The goal is to catch advanced liver disease earlier and reduce the impact of cirrhosis.

What this could mean

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

Active substance
A mobile app (OpenTele) that guides patients with fatty liver disease through lifestyle changes, paired with a dashboard for healthcare professionals
What this could lead to
If the app helps people stick to diet and exercise changes, it could slow or prevent the progression of fatty liver disease to cirrhosis and reduce the need for liver transplants.
What could go wrong
The trial is relatively small and tests feasibility, not long-term outcomes. People may not stay engaged with the app, and lifestyle changes are hard to maintain, so the approach might not work for everyone.

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 252 people

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

Started

Jan 2025

Expected to finish

Jan 2028

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

subjects with type 2 diabetes and/or metabolic syndrome and/or dyslipidemia and/or obesity (BMI\>30 Kg/m2) and/or familiar history for cirrhosis or liver cancer in the absence of known risk factors

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: * Diagnosed with MASLD and LSM\>= 10 kPa * Age \>= 18 years old * Sufficient digital literacy or supported from a caregiver with sufficient digital literacy * Smartphone (Android or iOS) able to download and run the App * Able to understand and communicate in Italian * Able to sign the informed consent Exclusion Criteria: * Major psychiatric disorder * Not able to use digital technologies

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Conditions

The condition(s) this trial relates to.

metabolic dysfunction-associated steatohepatitis metabolic dysfunction-associated steatotic liver disease

As listed by the trial registrant

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

NAFLD NASH

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD

    Rome, Lazio, 00168, Italy

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