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.
Study Type
OBSERVATIONAL
Enrollment
140
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Barcelona, Spain
RECRUITINGChange in Liver Frailty Index (LFI) score
Change in Liver Frailty Index (LFI) score from baseline to follow-up. Higher values indicate worsening frailty, whereas lower values indicate improvement in frailty.
Time frame: Baseline to Month 12
Fried Frailty Index
The Fried Frailty Index assesses frailty based on five components: unintentional weight loss, exhaustion, weakness, slow walking speed, and low physical activity. Higher scores indicate greater frailty. Positive change scores indicate worsening frailty, whereas negative change scores indicate improvement.
Time frame: Baseline to Month 12
Association Between Frailty and Functional Performance Measures
Association between frailty status (LFI and Fried Frailty Index) and functional performance assessed by gait speed, Timed Up and Go test, handgrip strength, and balance.
Time frame: Baseline to Month 12
Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers
Relationship between frailty status and circulating inflammatory, metabolic, and oxidative stress biomarkers.
Time frame: Baseline to Month 12.
Association Between Frailty and Hormonal Parameters
Relationship between frailty status and hormonal parameters, including female-specific variables such as menstrual status, menopausal status, and hormone replacement therapy use.
Time frame: Baseline to Month 12
Association Between Frailty and Body Composition
Relationship between frailty status and body composition parameters assessed by bioelectrical impedance analysis, including phase angle.
Time frame: Baseline to Month 12
Association Between Frailty and Gut Microbiota Composition
Relationship between frailty status and fecal microbiota composition assessed by shotgun metagenomic sequencing.
Time frame: Baseline to Month 12
Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem
Relationship between frailty status and cognitive performance, quality of life, illness perception, and self-esteem assessed using validated questionnaires.
Time frame: Baseline to Month 12
Association Between Frailty and Social Determinants of Health and Gender Roles
Relationship between frailty status and social determinants of health, health literacy, and gender-related factors.
Time frame: Baseline to Month 12
Development of an Artificial Intelligence-Based Frailty Risk Prediction Model
Development and evaluation of a predictive model integrating clinical, functional, biochemical, hormonal, microbiota, cognitive, psychosocial, and gender-related variables to identify patients at increased risk of frailty progression over one year.
Time frame: Baseline to Month 12
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