Secondary and Tertiary Digital Prevention of Non-alcoholic and Dysmetabolic Liver Disease (CALIBRE)

The prevalence of Metabolic dysfunction-associated steatotic liver disease (MASLD) and its severe form, Metabolic dysfunction-associated steatohepatitis (MASH), is high and they are increasingly becoming major causes of cirrhosis, hepatocellular carcinoma (HCC), and the need for liver transplantation. Due to the lack of noticeable symptoms during the early stages, the detection of MASLD is often delayed until the disease has advanced.

Currently, the treatment options MASLD are limited to lifestyle interventions such as dietary changes and physical activity. Despite the increasing prevalence of MASLD, there are no drugs available on the market specifically for this condition.

The goal is to made new model care which integrates the standard clinical procedures with a digital approach, namely a mobile application for patients and a clinical dashboard for healthcare professionals (HCPs), integrated with simple clinical data (anthropometric, laboratory and imaging data).

This study wants to test the feasibility of integrating a digital intervention to improve the patient engagement and linkage to care in order to identify the advanced MASLD at earliest stage (secondary prevention) and mitigate the impact of ongoing advanced liver disease helping patients to manage the long-term effect of disease.

To achieve this goal the study will leverage on a mobile app named OpenTele in order to test the adherence to lifestyle changes in patient with MASLD and on the connected clinical dashboard.

The app aims at integrating the standard clinical practice with digital technologies able to guide and support patients in order to seamlessly integrate secondary prevention strategies in their everyday life with 2 main aims:

• to implement a strategy for delay progression of liver disease;
• to reduce the effect of cirrhosis (tertiary prevention).

Study Overview

• Status: Recruiting
• Conditions: NAFLD; NASH

• Study Type: Observational
• Enrollment (Estimated): 252

Contacts and Locations

• Study Contact: Name: Luca Miele; Phone Number: +390630155701; Email: luca.miele@policlinicogemelli.it

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00168
      • Recruiting
      • Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Medicina Trapianti Fegato and UOC CEMAD
      • Principal Investigator: Luca Miele
      • Contact: Luca Miele; Phone Number: +390630155701; Email: luca.miele@policlinicogemelli.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Adherence (>80% over 4 weeks)	Assessed via smartphone (number of app access)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight reduction assessment	Number of subjects with a 12-month reduction between 7-10% of weight compared to baseline	12 month
Change in liver and spleen stiffness	Assessed by transient elastography	Baseline, after 4 weeks and 12 month
Change in Patient Reported Outcome questionnaire	Evaluation of overall physical well-being through the administration of questionnaires	12 weeks
Changes in measure energy expenditure	Cycle ergometer	12 month
Microbiome signature	Analysis of microbiome signature from feces	12 month
Clinical events	Record of number of hospitalization, decompensation, variceal bleeding, encephalopathy, ascites, liver cancer, liver transplantation, death	12 month

Collaborators and Investigators

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Investigators: Principal Investigator: Luca Miele, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2025
• Primary Completion (Estimated): February 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: September 26, 2024
• First Submitted That Met QC Criteria: March 14, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases
• Other Study ID Numbers: 6618 (CTEP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No