Muscle Mass Via UltraSound in Cirrhosis (MMUSCLE)

Sarcopenia Clinical Trial

— 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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06345547
• Other study ID #: EDGE 003539
• Status: Not yet recruiting
• Start date: May 2, 2024
• Est. completion date: May 31, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Antwerp
• Contact: Karolien Dams, MD
• Phone: +3238213635
• Email: karolien.dams[@]uza.be
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: May 31, 2027
• Est. primary completion date: May 2, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cirrhosis
• Fibrosis
• Liver Cirrhosis
• Malnutrition
• Sarcopenia

Intervention

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.

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Hepatology. 2021 Dec;74(6):3563. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Clin Gastroenterol Hepatol. 2022 Jun;20(6):1423. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	2 years
Secondary	Decompensation events: mortality • MELD evolution	clinical evolution of cirrhosis: Mortality 1 year after enrolment (Y/N)	2 years
Secondary	Decompensation events: transplantation • MELD evolution	clinical evolution of cirrhosis: Need for transplantation/transplant outcome (Y/N)	2 years
Secondary	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.	2 years
Secondary	Quality of life in cirrhosis	The effect of sarcopenia on the quality of life will be evaluated using the validated SarQoL® questionnaire.	2 years