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. (MASLD)

IIBSP-MAS-2025-133

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 Overview

• Status: Recruiting
• Conditions: Steatosis of Liver

• Study Type: Observational
• Enrollment (Estimated): 140

Contacts and Locations

• Study Contact: Name: Eva Román, Digestive Pathology Nurse; Phone Number: 0034630818580; Email: ERoman@santpau.cat
• Study Contact Backup: Name: German Soriano, Digestive Pathology MD; Email: gsoriano@santpau.cat

Study Locations

• Spain
  • Barcelona
    • Barcelona, Barcelona, Spain, 08031
      • Not yet recruiting
      • Hospital de la Santa Creu I Sant Pau
      • Contact: Eva Román, Digestive Pathology Nurse; Phone Number: 0034630818580; Email: ERoman@santpau.cat
      • Sub-Investigator: Elisabeth Pérez-Chust, Internal Medicine Nurse
      • Sub-Investigator: Rosalía Santesmases, EUI Sant Pau Nurse
      • Sub-Investigator: Maria Poca, Digestive Pathology MD PhD
      • Sub-Investigator: German Soriano, Digestive Pathology MD PhD
      • Sub-Investigator: Berta Cuyàs, Digestive Pathology MD PhD
      • Sub-Investigator: Idoia Genua, Endocrinology and Nutrition MD
      • Sub-Investigator: Marc Pons-Tarín, Microbiome Department Member
      • Sub-Investigator: Zoraida Moreno-Weidmann, Cardiology MD
    • Barcelona, Barcelona, Spain, 08031
      • Recruiting
      • Hospital de la Santa Creu I Sant Pau
      • Contact: Eva Román, Digestive Pathology Nurse; Phone Number: 0034-630818580; Email: ERoman@santpau.cat

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Eva Roman, Institut de Recerca IR Sant Pau

Study record dates

Study Major Dates

• Study Start (Estimated): May 26, 2026
• Primary Completion (Estimated): February 25, 2027
• Study Completion (Estimated): May 25, 2028

Study Registration Dates

• First Submitted: May 27, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 17, 2026

Study Record Updates

• Last Update Posted (Actual): June 17, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• 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.
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver
• Other Study ID Numbers: IIBSP-MAS-2025-133

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No