Assessing muscle loss in patients with chronic liver disease using ultrasound
Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study
This study is testing whether ultrasound can help find muscle loss in people with chronic liver disease, like cirrhosis or fatty liver, to improve their care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 125 (estimated) |
| Ages | 18 Years to 69 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma, RM) |
| Trial ID | NCT06101758 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the prevalence of sarcopenia in patients suffering from liver cirrhosis, non-alcoholic fatty liver disease, and hepatocellular carcinoma. It will utilize muscular ultrasound alongside other validated techniques like handgrip strength tests and total body DXA to diagnose sarcopenia. By comparing these methods, the study seeks to establish the reliability of ultrasound in detecting muscle loss and its association with clinical outcomes in these patients. The findings could provide valuable insights into the management of chronic liver disease.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with liver cirrhosis, non-alcoholic fatty liver disease, or hepatocellular carcinoma who can provide informed consent.
Not a fit: Patients with other significant gastrointestinal or neurological diseases that affect nutrition or muscle function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management of sarcopenia in patients with chronic liver disease, potentially enhancing patient outcomes.
How similar studies have performed: While the association between sarcopenia and poor outcomes in chronic liver disease is known, the use of muscular ultrasound for diagnosis in this context is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to express informed consent * 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: * inability to express informed consent * 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
Where this trial is running
Roma, RM
- Cemad — Roma, Rm, Italy (Recruiting)
Study contacts
- Study coordinator: Maria Assunta Zocco
- Email: Mariaassunta.zocco@policlinicogemelli.it
- Phone: 063015 1
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.