NCT Number: NCT06345547
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
Interested in participating?
Request Info18 year and older
All sexes
Observational
Edegem, Antwerpen, 2650, Belgium
Location status: Recruiting
Jolien Derdeyn, MD
CONTACT
+328213807 ext. 3807
Jolien Derdeyn, MD
SUB_INVESTIGATOR
Karolien Dams, MD
CONTACT
+3238213635 ext. 5175
Karolien Dams, MD
PRINCIPAL_INVESTIGATOR
Philippe Jorens, MD, PhD
SUB_INVESTIGATOR
Stany Perkisas, MD, PhD
SUB_INVESTIGATOR
Thomas Vanwolleghem, MD, Phd
SUB_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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.)
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.
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.)
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.
Time frame: 2 years
clinical evolution of cirrhosis: Mortality 1 year after enrolment (Y/N)
Time frame: 2 years
clinical evolution of cirrhosis: Need for transplantation/transplant outcome (Y/N)
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.
Time frame: 2 years
The effect of sarcopenia on the quality of life will be evaluated using the validated SarQoL® questionnaire.
Contact information is provided by the study sponsor or research team.
University Hospital, Antwerp
Other
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.
Acronym: MMUSCLE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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