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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients diagnosed with MASLD | Consecutive patients diagnosed with MASLD at any degree of fibrosis between the ages of 20 and 80 will be included. The main variable will be the degree of frailty assessed by the LFI and the Fried Index. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Baseline to Month 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Month 12 |
| Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers |
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Inclusion Criteria:
Exclusion Criteria:
> 30 g/day in men and > 20 g/day in women. AUDIT score: > 7 points in men, > 5 in women.
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eva Román, Digestive Pathology Nurse | Contact | 0034630818580 | ERoman@santpau.cat | |
| German Soriano, Digestive Pathology MD | Contact | gsoriano@santpau.cat |
| Name | Affiliation | Role |
|---|---|---|
| Eva Roman | Institut de Recerca IR Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital de la Santa Creu i Sant Pau | Not yet recruiting | Barcelona | Barcelona | 08031 | Spain |
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Relationship between frailty status and circulating inflammatory, metabolic, and oxidative stress biomarkers. |
| 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. | 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. | Baseline to Month 12 |
| Association Between Frailty and Gut Microbiota Composition | Relationship between frailty status and fecal microbiota composition assessed by shotgun metagenomic sequencing. | 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. | 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. | 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. | Baseline to Month 12 |
| Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Barcelona | 08031 | Spain |
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| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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