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

NCT ID: NCT06101758

Last Updated: 2023-10-26

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-20

Study Completion Date

2025-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cirrhosis Non-Alcoholic Fatty Liver Disease Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

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

Group Type EXPERIMENTAL

Handgrip strength test

Intervention Type DIAGNOSTIC_TEST

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

total body Dual Energy X-Ray Absorptiometry (DXA)

Intervention Type DIAGNOSTIC_TEST

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

Muscle ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Muscle ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Zocco Maria Assunta

Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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CEMAD

Roma, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Maria Assunta Zocco

Role: CONTACT

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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