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UNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers

RecruitingNAAges 18 Years - anyAllFundación Pública Andaluza para la gestión de la …
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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.
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What it tests

  • Multimodal lifestyle intervention
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Where

3 sites
Fondazione Policlinico Universitario Agostino Gemelli IRCCS. Internal Medicine and Liver Transplantation Unit
Roma, Italy
Hospital Universitario Virgen del Rocío de Sevilla
Seville, Spain
Hacettepe University
Ankara, Turkey (Türkiye)
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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