Steatosis of Liver
Conditions
Keywords
A condition characterized by the accumulation of fat in the liver, which is closely linked to metabolic disorders and occurs with low or no alcohol consumption.
Brief summary
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.
Interventions
None listed
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Liver Frailty Index (LFI) score | Baseline to Month 12 | 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 | Baseline to Month 12 | 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
| Measure | Time frame | Description |
|---|---|---|
| Association Between Frailty and Functional Performance Measures | Baseline to Month 12 | 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 | Baseline to Month 12. | Relationship between frailty status and circulating inflammatory, metabolic, and oxidative stress biomarkers. |
| Association Between Frailty and Hormonal Parameters | Baseline to Month 12 | 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 | Baseline to Month 12 | Relationship between frailty status and body composition parameters assessed by bioelectrical impedance analysis, including phase angle. |
| Association Between Frailty and Gut Microbiota Composition | Baseline to Month 12 | Relationship between frailty status and fecal microbiota composition assessed by shotgun metagenomic sequencing. |
| Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem | Baseline to Month 12 | Relationship between frailty status and cognitive performance, quality of life, illness perception, and self-esteem assessed using validated questionnaires. |
| Association Between Frailty and Social Determinants of Health and Gender Roles | Baseline to Month 12 | Relationship between frailty status and social determinants of health, health literacy, and gender-related factors. |
| Development of an Artificial Intelligence-Based Frailty Risk Prediction Model | Baseline to Month 12 | 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. |
Countries
Spain
Contacts
CONTACTEva Román, Digestive Pathology Nurse
CONTACTGerman Soriano, Digestive Pathology MD
PRINCIPAL_INVESTIGATOREva Roman
Institut de Recerca IR Sant Pau
Outcome results
None listed