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SarcopeniaMMUSCLENCT06345547

Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

An observational study of Sarcopenia and Cirrhosis, run by University Hospital, Antwerp at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question[s] it aims to answer are: what is the prevalence and development of sarcopenia in cirrhosis? what is the role of malnutrition? Participants will undergo a… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcopenia, Cirrhosis, Malnutrition
What is being tested?
ultrasound
How many people
60 participants
Where
1 siteBelgium
Study dates
6 May 2024to 31 Mar 2028
How long will I take part?
2 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: From our large population we will prospectively evaluate 60 patients with all 3 muscle parameters (US m quadriceps, US m thenar and hand grip strength). This will allow to calculate the incidence rate and relative risk of sarcopenia presence in this population. To keep the population homogeneous we will include patients according to the Child-Pugh classification with a balanced distribution between the subclasses.

Who may be able to join

  • diagnosis of cirrhosis and follow-up in the University Hospital of Antwerp

Who cannot join

  • known patient will against participation in the study or against the measures applied in the study
  • a decision made prior to inclusion to stop further treatment of the patient within the next 24 hours
  • no complete remission of malignancy including hepatocellular carcinoma within the past 12 months

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Stany Perkisas, MD, PhD contact

stany.perkisas@zna.be

Belgium1 site, 1 recruiting
  • University Hospital Antwerp

    Edegem, Antwerpen, 2650

    Karolien Dams, MD, +3238213635 ext. 5175, karolien.dams@uza.be

    Jolien Derdeyn, MD, +328213807 ext. 3807, jolien.derdeyn@uza.be

    Recruiting

Other trials in Belgium

About this study

Official title: Prospective Observational Cohort Survey to Assess the Prevalence and Development of Sarcopenia and the Correlation of Muscle Mass and Outcome in Patients With Cirrhosis by Skeletal Muscle Ultrasound.

The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength (sarcopenia) in patients with cirrhosis. The main question[s] it aims to answer are:

  • what is the prevalence and development of sarcopenia in cirrhosis?
  • what is the role of malnutrition? Participants will
  • undergo a muscle ultrasound of the lower and upper limb muscles
  • handgrip strength will be measured
  • malnutrition screening and assessment
  • complete a questionnaire to assess quality of life
Read the detailed description

In this study, the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis (n= 1346) of the University Hospital of Antwerp, using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles. Handgrip strength will be tested for muscle functional status. Findings will be correlated with clinical outcome (MELD, survival, decompensating events). The etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables, e.g. whether there is a difference between compensated vs. decompensated cirrhosis. The investigators will screen for malnutrition using the RFH-NPT and compare with the GLIM criteria. The effect of sarcopenia on the quality of life will be evaluated using the validated "SarQoL®" (Sarcopenia Quality of Life) questionnaire.

Being tested
ultrasound
Keywords
sarcopenia, cirrhosis, malnutrition, skeletal muscle ultrasound
Medical subject headings
Sarcopenia, Fibrosis, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ultrasoundOther

    Also called hand grip strength

    Ultrasound of m. quadriceps and m. thenar All ultrasound measurements will be performed in triplicate, with the average of the scores used in final analyses. Four parameters will be evaluated: muscle thickness, muscle cross sectional area, pennation angle and echo intensity (gain, depth and frequency will be kept constant).

    Hand grip strength measurement: measurement by an electronic hand dynamometer DynEx1TM (MD Systems, Inc. Ohio, USA). The recommendations for the handgrip strength test of the American Society of Hand Therapists will be followed: The maximum of the three values will be considered for analysis.

Study groups in NCT06345547
Study groupRoleWhat they receive
Child AThe impact of sarcopenia in patients with cirrhosis may also be influenced by sex, severity of hepatic dysfunction, and etiology of cirrhosis. For this reason we aim for an homogeneous population, with a balanced distribution over the Child Pugh classification with a homogeneous population of at least 50%. Child A patients still have a good hepatic function.
Receives: Other: ultrasound
Child BChild B patients have a moderately impaired hepatic function.
Receives: Other: ultrasound
Child CPatients with Child C have an advanced hepatic dysfunction, within this group we will also look at patients with acute on chronic liver failure.(ACLF)
Receives: Other: ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of sarcopenia: muscle mass

    Number of patients with prevalent sarcopenia. This will be assessed by skeletal muscle ultrasound (muscle thickness expressed in cm).

    Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition. This first outcome measure defines muscle mass.

    Measured: baseline

  2. Prevalence of sarcopenia: muscle strength

    Number of patients with prevalent sarcopenia. This will be assessed by handgrip strength (expressed in kg).

    Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition.

    As the definition contains both muscle mass and muscle strength, both factors have to be evaluated. This second outcome measure defines muscle strength.

    Measured: baseline

  3. Development of sarcopenia: changes in muscle mass

    Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define muscle mass: muscle thickness expressed in cm, cross sectional area in squared cm, pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)

    Measured: 2 years

  4. Development of sarcopenia: changes in muscle strength

    This will be assessed by handgrip strength (expressed in kg). Sarcopenia has been defined by the European Working Group on Sarcopenia as "a progressive and generalized skeletal muscle disorder associated with an increased likelihood of adverse outcomes including falls, fractures, disability, and mortality," combining both muscle mass and muscle strength or muscle performance in its definition.

    As the definition contains both muscle mass and muscle strength, both factors have to be evaluated.

    Measured: 2 years

  5. Development of sarcopenia: changes in muscle quality

    Changes in muscle mass by ultrasound muscle parameters from baseline up to 2 years follow-up. We will evaluate the muscle parameters that define quality of muscle: pennation angle in degrees and echo intensity expressed in arbitrary units (A.U.)

    Measured: 2 years

Secondary outcomes (5)
  1. Decompensation events: MELD score • MELD evolution

    clinical evolution of cirrhosis: MELD (Model of Endstage Liver Disease) score in points (range 7-40), with a higher score defining a worse state.

    Measured: 2 years

  2. Decompensation events: mortality • MELD evolution

    clinical evolution of cirrhosis: Mortality 1 year after enrolment (Y/N)

    Measured: 2 years

  3. Decompensation events: transplantation • MELD evolution

    clinical evolution of cirrhosis: Need for transplantation/transplant outcome (Y/N)

    Measured: 2 years

  4. Malnutrition

    The European Society for Clinical Nutrition and Metabolism guidelines recommend the Royal Free Hospital-Nutritional Prioritizing Tool (RFH-NPT) to identify malnutrition risk in patients with liver disease. The RFH-NPT categorises nutritional risk as low (0 points), medium (1 points) and high (2-7 points).

    The Global Leadership Initiative on Malnutrition (GLIM) has established a global consensus on the criteria for diagnosing malnutrition in adults in hospital settings. It is a two-step approach for the malnutrition diagnosis, i.e., first screening to identify "at risk" status by the use of any validated screening tool, and second, assessment for diagnosis and grading the severity of malnutrition; mild - moderate - severe.

    Measured: 2 years

  5. Quality of life in cirrhosis

    The effect of sarcopenia on the quality of life will be evaluated using the validated SarQoL® questionnaire.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2024
  2. Study start6 May 2024
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06345547
Sponsor's protocol ID
EDGE 003539
Acronym
MMUSCLE
Status last verified
Apr 2026
First submitted
14 Mar 2024
Last updated
1 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Individual participant data that underlie the results reported in the article, after deidentification (text, table, figures, appendices).

Publications

  • Dhaliwal A, Armstrong MJ. Sarcopenia in cirrhosis: A practical overview. Clin Med (Lond). 2020 Sep;20(5):489-492. doi: 10.7861/clinmed.2020-0089.

    PubMed 32934043
  • Lai JC, Tandon P, Bernal W, Tapper EB, Ekong U, Dasarathy S, Carey EJ. Malnutrition, Frailty, and Sarcopenia in Patients With Cirrhosis: 2021 Practice Guidance by the American Association for the Study of Liver Diseases. Hepatology. 2021 Sep;74(3):1611-1644. doi: 10.1002/hep.32049. No abstract available.

    PubMed 34233031
  • Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

    PubMed 31081853
  • Hsu CS, Kao JH. Sarcopenia and chronic liver diseases. Expert Rev Gastroenterol Hepatol. 2018 Dec;12(12):1229-1244. doi: 10.1080/17474124.2018.1534586. Epub 2018 Oct 16.

    PubMed 30791794
  • Carey EJ, Lai JC, Sonnenday C, Tapper EB, Tandon P, Duarte-Rojo A, Dunn MA, Tsien C, Kallwitz ER, Ng V, Dasarathy S, Kappus M, Bashir MR, Montano-Loza AJ. A North American Expert Opinion Statement on Sarcopenia in Liver Transplantation. Hepatology. 2019 Nov;70(5):1816-1829. doi: 10.1002/hep.30828. Epub 2019 Aug 19.

    PubMed 31220351
  • Tandon P, Low G, Mourtzakis M, Zenith L, Myers RP, Abraldes JG, Shaheen AA, Qamar H, Mansoor N, Carbonneau M, Ismond K, Mann S, Alaboudy A, Ma M. A Model to Identify Sarcopenia in Patients With Cirrhosis. Clin Gastroenterol Hepatol. 2016 Oct;14(10):1473-1480.e3. doi: 10.1016/j.cgh.2016.04.040. Epub 2016 May 14.

    PubMed 27189915
  • Watanabe Y, Yamada Y, Fukumoto Y, Ishihara T, Yokoyama K, Yoshida T, Miyake M, Yamagata E, Kimura M. Echo intensity obtained from ultrasonography images reflecting muscle strength in elderly men. Clin Interv Aging. 2013;8:993-8. doi: 10.2147/CIA.S47263. Epub 2013 Jul 25.

    PubMed 23926426
  • Perkisas S, Baudry S, Bauer J, Beckwee D, De Cock AM, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Marco E, Merello A, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Cruz-Jentoft A, Vandewoude M. Application of ultrasound for muscle assessment in sarcopenia: towards standardized measurements. Eur Geriatr Med. 2018 Dec;9(6):739-757. doi: 10.1007/s41999-018-0104-9. Epub 2018 Sep 17.

    PubMed 34674473
  • Stock MS, Thompson BJ. Echo intensity as an indicator of skeletal muscle quality: applications, methodology, and future directions. Eur J Appl Physiol. 2021 Feb;121(2):369-380. doi: 10.1007/s00421-020-04556-6. Epub 2020 Nov 21.

    PubMed 33221942
  • Iacob S, Mina V, Mandea M, Iacob R, Vadan R, Boar V, Ionescu G, Buzescu D, Gheorghe C, Gheorghe L. Assessment of Sarcopenia Related Quality of Life Using SarQoL(R) Questionnaire in Patients With Liver Cirrhosis. Front Nutr. 2022 Feb 25;9:774044. doi: 10.3389/fnut.2022.774044. eCollection 2022.

    PubMed 35284449
  • Perkisas S, Bastijns S, Baudry S, Bauer J, Beaudart C, Beckwee D, Cruz-Jentoft A, Gasowski J, Hobbelen H, Jager-Wittenaar H, Kasiukiewicz A, Landi F, Malek M, Marco E, Martone AM, de Miguel AM, Piotrowicz K, Sanchez E, Sanchez-Rodriguez D, Scafoglieri A, Vandewoude M, Verhoeven V, Wojszel ZB, De Cock AM. Application of ultrasound for muscle assessment in sarcopenia: 2020 SARCUS update. Eur Geriatr Med. 2021 Feb;12(1):45-59. doi: 10.1007/s41999-020-00433-9. Epub 2021 Jan 2.

    PubMed 33387359
  • Misirlioglu TO, Ozyemisci Taskiran O. Reliability of sonographic muscle thickness measurements of the thenar and hypothenar muscles. Muscle Nerve. 2018 Jan;57(1):E14-E17. doi: 10.1002/mus.25735. Epub 2017 Jul 18.

    PubMed 28662294
  • Pedrianes-Martin PB, Hernanz-Rodriguez GM, Gonzalez-Martin JM, Perez-Valera M, De Pablos-Velasco PL. Ultrasonographic Size of the Thenar Muscles of the Nondominant Hand Correlates with Total Body Lean Mass in Healthy Subjects. Acad Radiol. 2021 Apr;28(4):517-523. doi: 10.1016/j.acra.2020.02.029. Epub 2020 Jul 30.

    PubMed 32739076
  • Lopes J, Grams ST, da Silva EF, de Medeiros LA, de Brito CMM, Yamaguti WP. Reference equations for handgrip strength: Normative values in young adult and middle-aged subjects. Clin Nutr. 2018 Jun;37(3):914-918. doi: 10.1016/j.clnu.2017.03.018. Epub 2017 Mar 24.

    PubMed 28389120

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Cirrhosis, run by University Hospital, Antwerp at 1 site in Belgium.

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 1 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 May 2026. 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 Belgium. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Karolien Dams, MD (+3238213635 ext. 5175, karolien.dams@uza.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of sarcopenia: muscle mass (time frame: baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06345547, which also lists 14 linked publications.

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 1 May 2026.

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