UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers
Recruiting · NCT07652151 · Interventional (participants receive a specific treatment) · Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Overall design: The study will include one intervention based on Mediterranean diet plus structured lifestyle intervention (150 min/week of moderate-intensity or 75 min/week of high-intensity exercise) for a total of 16 weeks. Following a screening period of up to 12 months, eligible participants will be included in a single cohort. Study details include: * Study duration will be up to 36 months including the screening period. * Intervention will be up to 16 weeks. * Visit frequency will be every 4 weeks for the interventional period and every 12 weeks during follow-up.
Who can take part
Inclusion criteria
- Metabolic disarrangements following ATPIII criteria (i.e. comorbidities such as Type 2 diabetes, central obesity, BMI≥\>25 kg/m2, hypertension, dyslipidaemia.
- Written informed consent
- No dietetical counsellor/weight loss higher than 10% within the prior 6 months
- Age over 18 years old
- Liver stiffness measurement by Fibroscan ≥ 8, CAP ≥ 248 db/m and MRI PDFF ≥ 5%. ,
Exclusion criteria
- Significant alcohol intake (≥30 g/day in men and ≥20 g/day in women)
- Other causes of liver disease (evidence of viral or autoimmune hepatitis, HIV, drug-induced fatty liver or other metabolic liver diseases)
- Use of recreational drugs
- Decompensated acute or chronic liver disease
- Cirrhosis or transplant waitlist
- Pregnancy or parenteral nutrition
- No nutritional interventions, medications for weight loss or weight loss higher than 5% within the last year
- Presence of other comorbidities that would impact lifestyle intervention (i. e. prosthesis)
- Absence of a personal smartphone with a compatible operating system capable of supporting the Amazfit Bip 6 accelerometer app's functionalities: Android 7.0 or iOS 14.0, or later.
Where it is running
3 locations listed.
- Hacettepe University - Ankara, Turkey (Türkiye)
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit - Roma, Italy
- Hospital Universitario Virgen del Rocío de Sevilla - Seville, Spain