UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multimodal lifestyle intervention.
- Who it may be relevant to
- Registry conditions: MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy, Spain, Turkey (Türkiye)
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers - Study Protocol Version 2.0
Overview
Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort. Study details include: * Study duration will be up to 36 months including the screening period. * Intervention will be up to 16 weeks. * Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.
Detailed description
The UNMASK trial is a multicenter (Spain, Italy and Turkey), prospective, open-label lifestyle intervention based on tailored caloric restriction and monitored exercise. UNMASK aims to prove that the amelioration of MASLD at systemic and hepatic levels will be parallel to the improvement in our selected biomarkers. Given the known challenges with diagnosis and staging of MASH when using histopathological assessments of liver biopsies, the study will evaluate various blood-based non-invasive biomarkers. Non-invasive tests will be performed to asses endpoints. UNMASK includes a single arm in which patients undergo lifestyle changes, chiefly through the prescription of Mediterranean diet and physical exercise.
Interventions
- Behavioral Multimodal lifestyle intervention
Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks.
Primary outcome measures
- Number of Participants Achieving a Steatosis Response [Time frame: From baseline to month 16]
- Number of Participants Achieving Fibrosis Regression [Time frame: From baseline to month 16]
- Change From Baseline in Metabolic Dysfunction-Associated Steatohepatitis Resolution Index Score [Time frame: From baseline to month 16]
Secondary outcome measures (4)
- % Change in Weight [Time frame: From baseline to month 16]
- % Change in Waist Circumference [Time frame: From baseline to month 16]
- Change in Patient Reported Physical Activity [Time frame: From baseline to month 16]
- Change in Patient Reported Diet Habits by MEDAS Questionnaire [Time frame: From baseline to month 16]
Eligibility criteria
Inclusion criteria
- Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥>25 kg/m2, hypertension, dyslipidaemia.
- Written informed consent
- No dietetical counsellor/weight loss higher than 10% within the prior 6 months
- Age over 18 years old
- Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. ,
Exclusion criteria
- Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women)
- Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases)
- Use of recreational drugs
- Decompensated acute or chronic liver disease
- Cirrhosis or transplant waitlist
- Pregnancy or parenteral nutrition
- No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year
- Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis)
- Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver T — Roma
Spain · 1 center
- Hospital Universitario Virgen del Rocío de Sevilla — Seville
Turkey (Türkiye) · 1 center
- Hacettepe University — Ankara
Identifiers
NCT: NCT07652151 · UNMASK-EPPERMED2024-496 · EPPERMED2024-496