Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study
NCT ID: NCT06101758
Last Updated: 2023-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
125 participants
INTERVENTIONAL
2023-10-20
2025-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Muscular ultrasound assessment
Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma
Handgrip strength test
A handgrip strength test using a hydraulic hand dynamometer will be performed
total body Dual Energy X-Ray Absorptiometry (DXA)
A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed
Muscle ultrasound
A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed
Interventions
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Handgrip strength test
A handgrip strength test using a hydraulic hand dynamometer will be performed
total body Dual Energy X-Ray Absorptiometry (DXA)
A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed
Muscle ultrasound
A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of liver cirrhosis or non-alcoholic fatty liver disease or hepatocellular carcinoma based on clinical characteristics, biochemical serum tests and liver imaging examination or liver histologic examination if available
Exclusion Criteria
* pregnancy
* presence of a concomitant oncologic disease different from hepatocellular carcinoma
* presence of a concomitant gastrointestinal disease able to influence the absorption and digestion of nutrients (e.g. inflammatory bowel disease, celiac disease, short-bowel syndrome, congenital defects of metabolism)
* presence of a concomitant gastrointestinal or neurologic disease able to influence the ability of feeding (e.g. dysphagia, parkinson disease, neuromuscular diseases, diseases of the autonomic nervous system, cognitive impairment or dementia)
* chronic kidney disease from stage 3 B (IIIB) according to Kidney Disease: Improving Global Outcomes (KDIGO) classification (eGFR \<45ml/min/1.73m2)
* chronic heart failure from stage Ney York Heart Association (NYHA) II
* concomitant infection from Mycobacterium Tuberculosis or human immunodeficiency virus or chronic parasitic infections
18 Years
69 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Zocco Maria Assunta
Prof
Locations
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CEMAD
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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Maria Assunta Zocco
Role: primary
Other Identifiers
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5855
Identifier Type: -
Identifier Source: org_study_id
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