About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients will be included who are able to provide informed consent and actively participate in periodic assessments.
Disqualifiers
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.
Trial population
The degree of frailty will be compared between patients with MASLD and a cohort of individuals without liver disease. For this purpose, we have a historical cohort of 135 individuals without liver disease from primary care clinics whose frailty was assessed using the Fried frailty index. From this cohort, we will select participants by matching sex and age with the MASLD patients recruited for the present study.
Trial design
Case-only
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change 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.
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.
Secondary outcomes
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.
Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers
Relationship between frailty status and circulating inflammatory, metabolic, and oxidative stress biomarkers.
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.
Association Between Frailty and Body Composition
Relationship between frailty status and body composition parameters assessed by bioelectrical impedance analysis, including phase angle.
Sponsors and contacts
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