Studies

Observational Recruiting

NCT06345547 on ClinicalTrials.gov

Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

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.

  • Sponsor: Antwerp University Hospital
  • Enrollment: 60 (Estimated)
  • Study start: 2024-05-06 (Actual)
  • Primary completion: 2027-09-30 (Estimated)
  • Study completion: 2028-03-31 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief 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 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

Conditions

  • Sarcopenia
  • Cirrhosis
  • Malnutrition

Intervention / Treatment

  • Other: ultrasound

Primary Outcome Measures

  • Prevalence of sarcopenia: muscle mass (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.
  • Prevalence of sarcopenia: muscle strength (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.
  • Development of sarcopenia: changes in muscle mass (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.)
  • Development of sarcopenia: changes in muscle strength (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.
  • Development of sarcopenia: changes in muscle quality (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.)

Countries

Belgium

Locations and Investigators

  • University Hospital Antwerp, Edegem, Belgium (Recruiting)
    • Karolien Dams, MD
    • Jolien Derdeyn, MD
    • Jolien Derdeyn, MD
    • Thomas Vanwolleghem, MD, Phd
    • Philippe Jorens, MD, PhD
    • Stany Perkisas, MD, PhD
    • Karolien Dams, MD (Principal Investigator)

Study Officials