Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study

NCT06101758 | Unknown

• 1 other identifier: 5855
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is a complex multifactorial syndrome which could be present in older age (primary sarcopenia) or earlier in chronic disease (secondary sarcopenia). Even if in patients with chronic liver disease an association among sarcopenia and poor clinical outcomes is well known, the data available about the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma are very variable according to the populations in object and, furthermore, few data are available regarding the use of muscular ultrasound to detect this condition. The aim of this study is to define the prevalence of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma in follow-up at our center and the clinical outcomes associated with this condition, and to determine the reliability of muscular ultrasound to diagnose the condition of sarcopenia through a comparison with other validated techniques such as computed tomography, magnetic resonance imaging and dual-energy X-ray absorptiometry.

Conditions

Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease; Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma

  24 months

Secondary Outcomes (4)

• Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis

  24 months

• To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease

  24 months

• To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma

  24 months

• To calculate cohen's Kappa to evaluate the concordance among muscular ultrasound and dual-energy X-ray absorption, computed tomography scan and magnetic resonance imaging in the detection of sarcopenia

  24 months

Study Arms (1)

Muscular ultrasound assessment

EXPERIMENTAL

Adult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma

Diagnostic Test: Handgrip strength test; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA); Diagnostic Test: Muscle ultrasound

Interventions

Handgrip strength test DIAGNOSTIC_TEST

A handgrip strength test using a hydraulic hand dynamometer will be performed

Muscular ultrasound assessment

total body Dual Energy X-Ray Absorptiometry (DXA) DIAGNOSTIC_TEST

A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed

Muscular ultrasound assessment

Muscle ultrasound DIAGNOSTIC_TEST

A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed

Muscular ultrasound assessment

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

CEMAD

Roma, RM, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Non-alcoholic Fatty Liver Disease; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Fatty Liver; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Central Study Contacts

Maria Assunta Zocco

CONTACT

063015 1; Mariaassunta.zocco@policlinicogemelli.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 26, 2023
• Study Start: October 20, 2023
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2025
• Last Updated: October 26, 2023

Record last verified: 2023-10

Locations

IT (1)