Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE) (MMUSCLE)

April 27, 2026 updated by: Karolien Dams, University Hospital, Antwerp

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Recruiting
        • University Hospital Antwerp
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Jolien Derdeyn, MD
        • Sub-Investigator:
          • Thomas Vanwolleghem, MD, Phd
        • Sub-Investigator:
          • Philippe Jorens, MD, PhD
        • Sub-Investigator:
          • Stany Perkisas, MD, PhD
        • Principal Investigator:
          • Karolien Dams, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Child A

The 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.
Other: ultrasound

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.

Other Names:
  • hand grip strength
Child B
Child B patients have a moderately impaired hepatic function.
Other: ultrasound

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.

Other Names:
  • hand grip strength
Child C
Patients with Child C have an advanced hepatic dysfunction, within this group we will also look at patients with acute on chronic liver failure.(ACLF)
Other: ultrasound

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.

Other Names:
  • hand grip strength

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of sarcopenia: muscle mass
Time Frame: baseline

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.
baseline
Prevalence of sarcopenia: muscle strength
Time Frame: baseline

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.
baseline
Development of sarcopenia: changes in muscle mass
Time Frame: 2 years
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.)
2 years
Development of sarcopenia: changes in muscle strength
Time Frame: 2 years

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.
2 years
Development of sarcopenia: changes in muscle quality
Time Frame: 2 years
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.)
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decompensation events: MELD score • MELD evolution
Time Frame: 2 years
clinical evolution of cirrhosis: MELD (Model of Endstage Liver Disease) score in points (range 7-40), with a higher score defining a worse state.
2 years
Decompensation events: mortality • MELD evolution
Time Frame: 2 years
clinical evolution of cirrhosis: Mortality 1 year after enrolment (Y/N)
2 years
Decompensation events: transplantation • MELD evolution
Time Frame: 2 years
clinical evolution of cirrhosis: Need for transplantation/transplant outcome (Y/N)
2 years
Malnutrition
Time Frame: 2 years

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.
2 years
Quality of life in cirrhosis
Time Frame: 2 years
The effect of sarcopenia on the quality of life will be evaluated using the validated SarQoL® questionnaire.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Antwerp

Investigators

  • Principal Investigator: Karolien Dams, MD, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2024

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 27, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EDGE 003539

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Individual participant data that underlie the results reported in the article, after deidentification (text, table, figures, appendices).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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