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

• Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06101758
• Collaborator: (none)
• Enrollment: 125
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 20.4
• Patients Per Site Per Month: 6.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Liver Cirrhosis; Non-Alcoholic Fatty Liver Disease; Hepatocellular Carcinoma	Diagnostic Test: Handgrip strength test; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA); Diagnostic Test: Muscle ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 125 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study
• Actual Study Start Date: Oct 20, 2023
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2025

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Muscular ultrasound assessment 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; A handgrip strength test using a hydraulic hand dynamometer will be performed; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA); A total body Dual Energy X-Ray Absorptiometry (DXA) to estimate muscle mass will be performed; Diagnostic Test: Muscle ultrasound; A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis [24 months]

2. To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease [24 months]

3. To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma [24 months]

4. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CEMAD	Roma	RM	Italy	00168

Sponsors and Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zocco Maria Assunta, Prof, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• ClinicalTrials.gov Identifier: NCT06101758
• Other Study ID Numbers: 5855
• First Posted: Oct 26, 2023
• Last Update Posted: Oct 26, 2023
• Last Verified: Oct 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Sarcopenia

Study Results

No Results Posted as of Oct 26, 2023