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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-80
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

140 Participants
are grouped into 1 trial group
Group A: Patients diagnosed with MASLD

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline to Month 12
2

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

Secondary outcomes

1

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
2

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.
3

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
4

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

Other outcomes

Sponsors and contacts

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