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

NCT06879236 | Recruiting

• 1 other identifier: 6618
• Study Type: observational
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

NASH; NAFLD

Outcome Measures

Primary Outcomes (1)

• App Adherence (>80% over 4 weeks)

  Assessed via smartphone (number of app access)

  4 weeks

Secondary Outcomes (6)

• Weight reduction assessment

  12 month

• Change in liver and spleen stiffness

  Baseline, after 4 weeks and 12 month

• Change in Patient Reported Outcome questionnaire

  12 weeks

• Changes in measure energy expenditure

  12 month

• Microbiome signature

  12 month

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Major psychiatric disorder
• Not able to use digital technologies

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

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

Rome, Lazio, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Luca Miele

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Miele

CONTACT

+390630155701; luca.miele@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2024
• First Posted: March 17, 2025
• Study Start: January 16, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

IT (1)