Impact of Steatotic Liver Disease Associated With Metabolic Dysfunction (MASLD) on Frailty, Cognition, and Quality of Life. A Gender-sensitive Approach Towards a Comprehensive and Equitable Perspective.
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Steatosis of Liver. Basic parameters: 20 years — 80 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
- Spain
- 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
IIBSP-MAS-2025-133
Overview
The goal of this observational study is to determine the differences in the prevalence, characteristics and evolution of frailty between men and women diagnosed with MASLD, and to establish its relationship with clinical, functional, hormonal and social parameters.
Primary outcome measures
- Change in Liver Frailty Index (LFI) score [Time frame: Baseline to Month 12]
- Fried Frailty Index [Time frame: Baseline to Month 12]
Secondary outcome measures (8)
- Association Between Frailty and Functional Performance Measures [Time frame: Baseline to Month 12]
- Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers [Time frame: Baseline to Month 12.]
- Association Between Frailty and Hormonal Parameters [Time frame: Baseline to Month 12]
- Association Between Frailty and Body Composition [Time frame: Baseline to Month 12]
- Association Between Frailty and Gut Microbiota Composition [Time frame: Baseline to Month 12]
- Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem [Time frame: Baseline to Month 12]
- Association Between Frailty and Social Determinants of Health and Gender Roles [Time frame: Baseline to Month 12]
- Development of an Artificial Intelligence-Based Frailty Risk Prediction Model [Time frame: Baseline to Month 12]
Eligibility criteria
Inclusion criteria
- Patients will be included who are able to provide informed consent and actively participate in periodic assessments.
Exclusion criteria
- Risky alcohol consumption:
> 30 g/day in men and > 20 g/day in women. AUDIT score: > 7 points in men, > 5 in women.
- Other liver diseases (viral hepatitis, autoimmune hepatitis, etc.).
- Advanced neurodegenerative diseases or severe psychiatric disorders.
- Severe comorbidities or treatments that, in the researchers' judgment, may affect frailty and quality of life more than metabolic syndrome and liver disease.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Spain · 2 centers
- Hospital de la Santa Creu i Sant Pau — Barcelona
- Hospital de la Santa Creu i Sant Pau — Barcelona
Identifiers
NCT: NCT07652892 · IIBSP-MAS-2025-133