Status:
RECRUITING
Patients' Perspectives on Metabolic Dysfunction-associated Steatohepatitis: a Qualitative Study
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Conditions:
Metabolic Dysfunction Associated Steatohepatitis (MASH)
Eligibility:
All Genders
18-75 years
Brief Summary
The aim of this qualitative study is to explore and identify the expectations, perceptions, attitudes, needs, and knowledge related to the management of metabolic dysfunction-associated steatohepatiti...
Eligibility Criteria
Inclusion
- Patients who voluntarily agree to participate in the MASH-Cardiovascular Programme.
- Patients followed in the outpatient hepatology/gastroenterology clinic at Hospital de Sant Pau with a diagnosis of MASH and fibrosis stage F2-F4.
- Patients aged between 18 and 75 years.
- Patients with a BMI ≥ 27 kg/m².
- Patients who consent to participate in the study-specific interviews.
Exclusion
- Patients who do not agree to participate in the study-specific interviews.
- Patients meeting exclusion criteria of the MASH-Cardiovascular Programme:
- Patients with decompensated liver cirrhosis.
- Patients who are vegetarians or have dietary habits/preferences that prevent adherence to standard-of-care nutritional guidelines.
- Patients with moderate-to-severe alcohol consumption (\>20 g/day for women and \>40 g/day for men).
- Patients with an eGFR \< 30 mL/min.
- Patients with malnutrition.
- Patients with type 1 diabetes or other forms of diabetes.
- Patients who are candidates for bariatric surgery.
- Patients with active malignancy.
- Patients with advanced or unstable heart failure.
- Patients with eating disorders or severe psychiatric illness.
- Patients currently enrolled in another clinical trial.
- Pregnant women or women planning to become pregnant.
Key Trial Info
Start Date :
June 3 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 20 2028
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07188220
Start Date
June 3 2025
End Date
January 20 2028
Last Update
September 23 2025
Active Locations (2)
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1
IR Sant Pau
Barcelona, Spain, 08041
2
IR Sant Pau
Barcelona, Spain