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)
11. juni 2026 opdateret af: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Observationel
Tilmelding (Anslået)
140
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Eva Román, Digestive Pathology Nurse
- Telefonnummer: 0034630818580
- E-mail: ERoman@santpau.cat
Undersøgelse Kontakt Backup
- Navn: German Soriano, Digestive Pathology MD
- E-mail: gsoriano@santpau.cat
Studiesteder
-
-
Barcelona
-
Barcelona, Barcelona, Spanien, 08031
- Ikke rekrutterer endnu
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Eva Román, Digestive Pathology Nurse
- Telefonnummer: 0034630818580
- E-mail: ERoman@santpau.cat
-
Underforsker:
- Elisabeth Pérez-Chust, Internal Medicine Nurse
-
Underforsker:
- Rosalía Santesmases, EUI Sant Pau Nurse
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Underforsker:
- Maria Poca, Digestive Pathology MD PhD
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Underforsker:
- German Soriano, Digestive Pathology MD PhD
-
Underforsker:
- Berta Cuyàs, Digestive Pathology MD PhD
-
Underforsker:
- Idoia Genua, Endocrinology and Nutrition MD
-
Underforsker:
- Marc Pons-Tarín, Microbiome Department Member
-
Underforsker:
- Zoraida Moreno-Weidmann, Cardiology MD
-
Barcelona, Barcelona, Spanien, 08031
- Rekruttering
- Hospital de La Santa Creu i Sant Pau
-
Kontakt:
- Eva Román, Digestive Pathology Nurse
- Telefonnummer: 0034-630818580
- E-mail: ERoman@santpau.cat
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Liver Frailty Index (LFI) score
Tidsramme: 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.
|
Baseline to Month 12
|
|
Fried Frailty Index
Tidsramme: 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.
|
Baseline to Month 12
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Association Between Frailty and Functional Performance Measures
Tidsramme: 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.
|
Baseline to Month 12
|
|
Association Between Frailty and Inflammatory, Metabolic, and Oxidative Stress Biomarkers
Tidsramme: Baseline to Month 12.
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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
Tidsramme: 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.
|
Baseline to Month 12
|
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Association Between Frailty and Body Composition
Tidsramme: Baseline to Month 12
|
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
Tidsramme: Baseline to Month 12
|
Relationship between frailty status and fecal microbiota composition assessed by shotgun metagenomic sequencing.
|
Baseline to Month 12
|
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Association Between Frailty and Cognitive Function, Quality of Life, and Self-Esteem
Tidsramme: Baseline to Month 12
|
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
Tidsramme: Baseline to Month 12
|
Relationship between frailty status and social determinants of health, health literacy, and gender-related factors.
|
Baseline to Month 12
|
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Development of an Artificial Intelligence-Based Frailty Risk Prediction Model
Tidsramme: 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.
|
Baseline to Month 12
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Eva Roman, Institut de Recerca IR Sant Pau
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
26. maj 2026
Primær færdiggørelse (Anslået)
25. februar 2027
Studieafslutning (Anslået)
25. maj 2028
Datoer for studieregistrering
Først indsendt
27. maj 2026
Først indsendt, der opfyldte QC-kriterier
11. juni 2026
Først opslået (Faktiske)
17. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
17. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIBSP-MAS-2025-133
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