Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

NCT06345547 | Recruiting

• 1 other identifier: EDGE 003539
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

sarcopenia; cirrhosis; malnutrition; skeletal muscle ultrasound

Outcome Measures

Primary Outcomes (5)

• 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.

  baseline

• 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.

  baseline

• 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.)

  2 years

• 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.

  2 years

• 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.)

  2 years

Secondary Outcomes (5)

• Decompensation events: MELD score • MELD evolution

  2 years

• Decompensation events: mortality • MELD evolution

  2 years

• Decompensation events: transplantation • MELD evolution

  2 years

• Malnutrition

  2 years

• Quality of life in cirrhosis

  2 years

Study Arms (3)

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

Child B

Child B patients have a moderately impaired hepatic function.

Other: ultrasound

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

Interventions

ultrasound OTHER

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.

Also known as: hand grip strength

Child A; Child B; Child C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• known patient will against participation in the study or against the measures applied in the study
• no complete remission of malignancy including hepatocellular carcinoma within the past 12 months

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

University Hospital Antwerp

Edegem, Antwerpen, 2650, Belgium

RECRUITING

Related Publications (14)

• 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.

  PMID: 32934043 BACKGROUND

• 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.

  PMID: 34233031 BACKGROUND

• 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.

  PMID: 31081853 BACKGROUND

• 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.

  PMID: 30791794 BACKGROUND

• 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.

  PMID: 31220351 BACKGROUND

• 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.

  PMID: 27189915 BACKGROUND

• 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.

  PMID: 23926426 BACKGROUND

• 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.

  PMID: 34674473 BACKGROUND

• 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.

  PMID: 33221942 BACKGROUND

• 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.

  PMID: 35284449 BACKGROUND

• 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.

  PMID: 33387359 BACKGROUND

• 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.

  PMID: 28662294 BACKGROUND

• 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.

  PMID: 32739076 BACKGROUND

• 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.

  PMID: 28389120 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Fibrosis; Malnutrition

Interventions

High-Energy Shock Waves; Hand Strength

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pathologic Processes; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Muscle Strength; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karolien Dams, MD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karolien Dams, MD

CONTACT

+3238213635; karolien.dams@uza.be

Stany Perkisas, MD, PhD

CONTACT

stany.perkisas@zna.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD, senior staff intensive care

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 3, 2024
• Study Start: May 6, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

BE (1)