Influence of Sarcopenia on the Course of the Diseases

NCT06829290 | Recruiting

• 1 other identifier: 2024-17561
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty is a geriatric syndrome that primarily affects older patients, but also patients with severe illnesses. It is particularly common among oncology patients, but also among patients with gastrointestinal diseases such as liver cirrhosis or pancreatitis. Sarcopenia, a form of frailty, is defined as a loss of muscle quantity, quality and function. Currently, complex methods such as CT or bioimpedance measurement are available. However, simpler techniques such as ultrasound-based measurement could be alternatives, but still require further validation. In addition, serological muscle markers could support and simplify diagnostics. The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using ultrasound and biomarkers.

Conditions

Liver Cirrhosis; Cancer; Cachexia; Sarcopenia; Mechanical Ventilation

Keywords

sarcopenia; ultrasound

Outcome Measures

Primary Outcomes (1)

• Complication

  Number of patients with decompensation of the underlying disease (e.g. liver cirrhosis: hyropic decompensation) or hospitalisation or death

  From the date of enrollment until the date of first documented complication (decopmensation, hospitalisation, death) from any cause whichever came first, assessed up to two years

Interventions

Ultrasound DIAGNOSTIC_TEST

Sonographisch measurement of muscles Blood muscle markers

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

oncological patient in the field of gastrointestinal tumors patients with liver cirrhosis patients attending the intensive care unit

You may qualify if:

• oncological patient in the field of gastrointestinal tumors
• patients with liver cirrhosis
• patients attending the intensive care unit

You may not qualify if:

• patients incapable of consenting
• patients with congenital muscle diseases

Sponsors & Collaborators

• Universitatsmedizin Mainz - 1. Medizinische Klinik: lead

Study Sites (1)

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

Related Publications (18)

• Lena A, Hadzibegovic S, von Haehling S, Springer J, Coats AJ, Anker MS. Sarcopenia and cachexia in chronic diseases: from mechanisms to treatment. Pol Arch Intern Med. 2021 Dec 22;131(12):16135. doi: 10.20452/pamw.16135. Epub 2021 Nov 15.

  PMID: 34775741 BACKGROUND

• Kremer WM, Labenz C, Kuchen R, Sagoschen I, Bodenstein M, Schreiner O, Worns MA, Sivanathan V, Weinmann A, Galle PR, Sprinzl MF. Sonographic assessment of low muscle quantity identifies mortality risk during COVID-19: a prospective single-centre study. J Cachexia Sarcopenia Muscle. 2022 Feb;13(1):169-179. doi: 10.1002/jcsm.12862. Epub 2021 Dec 8.

  PMID: 34881516 BACKGROUND

• Pinto Dos Santos D, Kloeckner R, Koch S, Hoppe-Lotichius M, Zoller D, Toenges G, Kremer WM, Zimmermann T, Mittler J, Lang H, Duber C, Galle PR, Weinmann A, Sprinzl MF. Sarcopenia as prognostic factor for survival after orthotopic liver transplantation. Eur J Gastroenterol Hepatol. 2020 May;32(5):626-634. doi: 10.1097/MEG.0000000000001552.

  PMID: 31725030 BACKGROUND

• Zhang JX, Yan HT, Ding Y, Liu J, Liu S, Zu QQ, Shi HB. Low Psoas-Muscle index is associated with decreased survival in hepatocellular carcinoma treated with transarterial chemoembolization. Ann Med. 2022 Dec;54(1):1562-1569. doi: 10.1080/07853890.2022.2081872.

  PMID: 35639492 BACKGROUND

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• Hari A, Berzigotti A, Stabuc B, Caglevic N. Muscle psoas indices measured by ultrasound in cirrhosis - Preliminary evaluation of sarcopenia assessment and prediction of liver decompensation and mortality. Dig Liver Dis. 2019 Nov;51(11):1502-1507. doi: 10.1016/j.dld.2019.08.017. Epub 2019 Sep 20.

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• Takai Y, Katsumata Y, Kawakami Y, Kanehisa H, Fukunaga T. Ultrasound method for estimating the cross-sectional area of the psoas major muscle. Med Sci Sports Exerc. 2011 Oct;43(10):2000-4. doi: 10.1249/MSS.0b013e31821994cb.

  PMID: 21448087 BACKGROUND

• McLean RR, Shardell MD, Alley DE, Cawthon PM, Fragala MS, Harris TB, Kenny AM, Peters KW, Ferrucci L, Guralnik JM, Kritchevsky SB, Kiel DP, Vassileva MT, Xue QL, Perera S, Studenski SA, Dam TT. Criteria for clinically relevant weakness and low lean mass and their longitudinal association with incident mobility impairment and mortality: the foundation for the National Institutes of Health (FNIH) sarcopenia project. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):576-83. doi: 10.1093/gerona/glu012.

  PMID: 24737560 BACKGROUND

• Cawthon PM, Peters KW, Shardell MD, McLean RR, Dam TT, Kenny AM, Fragala MS, Harris TB, Kiel DP, Guralnik JM, Ferrucci L, Kritchevsky SB, Vassileva MT, Studenski SA, Alley DE. Cutpoints for low appendicular lean mass that identify older adults with clinically significant weakness. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):567-75. doi: 10.1093/gerona/glu023.

  PMID: 24737559 BACKGROUND

• Cruz-Jentoft AJ, Sayer AA. Sarcopenia. Lancet. 2019 Jun 29;393(10191):2636-2646. doi: 10.1016/S0140-6736(19)31138-9. Epub 2019 Jun 3.

  PMID: 31171417 BACKGROUND

• Durand F, Buyse S, Francoz C, Laouenan C, Bruno O, Belghiti J, Moreau R, Vilgrain V, Valla D. Prognostic value of muscle atrophy in cirrhosis using psoas muscle thickness on computed tomography. J Hepatol. 2014 Jun;60(6):1151-7. doi: 10.1016/j.jhep.2014.02.026. Epub 2014 Mar 6.

  PMID: 24607622 BACKGROUND

• Benz E, Trajanoska K, Lahousse L, Schoufour JD, Terzikhan N, De Roos E, de Jonge GB, Williams R, Franco OH, Brusselle G, Rivadeneira F. Sarcopenia in COPD: a systematic review and meta-analysis. Eur Respir Rev. 2019 Nov 13;28(154):190049. doi: 10.1183/16000617.0049-2019. Print 2019 Dec 31.

  PMID: 31722892 BACKGROUND

• Shachar SS, Williams GR, Muss HB, Nishijima TF. Prognostic value of sarcopenia in adults with solid tumours: A meta-analysis and systematic review. Eur J Cancer. 2016 Apr;57:58-67. doi: 10.1016/j.ejca.2015.12.030. Epub 2016 Feb 13.

  PMID: 26882087 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 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.

  PMID: 30312372 BACKGROUND

• Cruz-Jentoft AJ, Baeyens JP, Bauer JM, Boirie Y, Cederholm T, Landi F, Martin FC, Michel JP, Rolland Y, Schneider SM, Topinkova E, Vandewoude M, Zamboni M; European Working Group on Sarcopenia in Older People. Sarcopenia: European consensus on definition and diagnosis: Report of the European Working Group on Sarcopenia in Older People. Age Ageing. 2010 Jul;39(4):412-23. doi: 10.1093/ageing/afq034. Epub 2010 Apr 13.

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  PMID: 21093718 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

EDTA 7,5 ml

MeSH Terms

Conditions

Liver Cirrhosis; Neoplasms; Cachexia; Sarcopenia

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Weight Loss; Body Weight Changes; Body Weight; Signs and Symptoms; Thinness; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Wolfgang Maximilian Kremer Kremer, MD

CONTACT

00496131175711; maximilian.kremer@unimedizin-mainz.de

Christian Labenz Labenz, MD

CONTACT

0049 6131174209

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior physician

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 17, 2025
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

DE (1)