Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Steatose av lever

Studietype

Observasjonsmessig

Registrering (Antatt)

140

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Navn: Eva Román, Digestive Pathology Nurse
Telefonnummer: 0034630818580
E-post: ERoman@santpau.cat

Studer Kontakt Backup

Navn: German Soriano, Digestive Pathology MD
E-post: gsoriano@santpau.cat

Studiesteder

Spania
- Barcelona
  - Barcelona, Barcelona, Spania, 08031
    - Har ikke rekruttert ennå
    - Hospital de La Santa Creu i Sant Pau
    - Ta kontakt med:
      
      Eva Román, Digestive Pathology Nurse
      
      Telefonnummer: 0034630818580
      
      E-post: ERoman@santpau.cat
    - Underetterforsker:
      
      Elisabeth Pérez-Chust, Internal Medicine Nurse
    - Underetterforsker:
      
      Rosalía Santesmases, EUI Sant Pau Nurse
    - Underetterforsker:
      
      Maria Poca, Digestive Pathology MD PhD
    - Underetterforsker:
      
      German Soriano, Digestive Pathology MD PhD
    - Underetterforsker:
      
      Berta Cuyàs, Digestive Pathology MD PhD
    - Underetterforsker:
      
      Idoia Genua, Endocrinology and Nutrition MD
    - Underetterforsker:
      
      Marc Pons-Tarín, Microbiome Department Member
    - Underetterforsker:
      
      Zoraida Moreno-Weidmann, Cardiology MD
  - Barcelona, Barcelona, Spania, 08031
    - Rekruttering
    - Hospital de La Santa Creu i Sant Pau
    - Ta kontakt med:
      
      Eva Román, Digestive Pathology Nurse
      
      Telefonnummer: 0034-630818580
      
      E-post: ERoman@santpau.cat

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Voksen
Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Antall grupper / kohorter

Kohorter og intervensjoner

Gruppe / Kohort
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.

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	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	Tiltaksbeskrivelse	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.	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
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
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
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Etterforskere

Hovedetterforsker: Eva Roman, Institut de Recerca IR Sant Pau

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

26. mai 2026

Primær fullføring (Antatt)

25. februar 2027

Studiet fullført (Antatt)

25. mai 2028

Datoer for studieregistrering

Først innsendt

27. mai 2026

Først innsendt som oppfylte QC-kriteriene

11. juni 2026

Først lagt ut (Faktiske)

17. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)