Liver CirrhosisSARCOLIVERNCT06101758
Ultrasound Assessment of Sarcopenia in Patients With Chronic Liver Disease: the SARCOLIVER Study
A study testing Handgrip strength test, total body Dual Energy X-Ray Absorptiometry (DXA) and Muscle ultrasound in people with Liver Cirrhosis and Non-Alcoholic Fatty Liver Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Liver Cirrhosis, Non-Alcoholic Fatty Liver Disease, Hepatocellular Carcinoma
- What is being tested?
- Handgrip strength test, total body Dual Energy X-Ray Absorptiometry (DXA) and Muscle ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteItaly
- Study dates
- 20 Oct 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study
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.
- Being tested
- Handgrip strength test, total body Dual Energy X-Ray Absorptiometry (DXA), Muscle ultrasound
- Medical subject headings
- Liver Cirrhosis, Non-alcoholic Fatty Liver Disease, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Handgrip strength testDiagnostic test
A handgrip strength test using a hydraulic hand dynamometer will be performed
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
Muscle ultrasoundDiagnostic test
A muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Handgrip strength test; Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA); Diagnostic Test: Muscle ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma
Measured: 24 months
Secondary outcomes (4)
Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis
Measured: 24 months
To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease
Measured: 24 months
To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start20 Oct 2023
- Primary completionJul 2024 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zocco Maria Assunta, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06101758
- Sponsor's protocol ID
- 5855
- Acronym
- SARCOLIVER
- Status last verified
- Oct 2023
- First submitted
- 4 Sep 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Ultrasound Assessment of Sarcopenia and Correlated Clinical Outcomes in Patients With Chronic Liver Disease: the SARCOLIVER Study
- ClinicalTrials.gov ID
- NCT06101758
- Acronym / sponsor ID
- SARCOLIVER / 5855
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 20 Oct 2023 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Muscular ultrasound assessment | Experimental | Diagnostic Test: Handgrip strength test, Diagnostic Test: total body Dual Energy X-Ray Absorptiometry (DXA), Diagnostic Test: Muscle ultrasoundAdult patients aged 18-69 years with a diagnosis of either liver cirrhosis, non-alcoholic fatty liver disease or hepatocellular carcinoma |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Handgrip strength testA handgrip strength test using a hydraulic hand dynamometer will be performed | Diagnostic test | Muscular ultrasound assessment |
| 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 | Muscular ultrasound assessment |
| Muscle ultrasoundA muscular ultrasound of abdominal muscles, forearm muscles, quadriceps and gastrocnemius will be performed | Diagnostic test | Muscular ultrasound assessment |
Primary outcome
To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma
Time frame: 24 months
4 secondary outcomes
Association among sarcopenia and survival or acute decompensation events in patients with liver cirrhosis
Time frame: 24 months
To calculate the prevalence of obesity with sarcopenia in patients with non-alcoholic fatty liver disease
Time frame: 24 months
To evaluate the association among sarcopenia and therapeutic response in patients with hepatocellular carcinoma
Time frame: 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
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Handgrip strength test, total body Dual Energy X-Ray Absorptiometry (DXA) and Muscle ultrasound in people with Liver Cirrhosis and Non-Alcoholic Fatty Liver Disease, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria Assunta Zocco (063015 1, Mariaassunta.zocco@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To calculate the prevalence of the condition of sarcopenia in patients with liver cirrhosis, non-alcoholic fatty liver disease and hepatocellular carcinoma (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023.