Influence of Sarcopenia on the Course of the Diseases

Official title

Influence of Sarcopenia on the Course of the Diseases - Measured Using Ultrasound and Biochemical Markers

Overview

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.

Detailed description

Frailty is a well-known syndrome that has a negative impact on many diseases and the course of disease. Patients affected by frailty are particularly vulnerable due to their inadequate ability to deal with extrinsic and intrinsic stressors. The prevalence of frailty increases with age, affecting 15% of people over the age of 65 and 25% of people over the age of 80.

Frailty is the end result of an interplay between malnutrition, cognitive impairment and muscle wasting. Each of these factors can be further examined and measured, but they also influence each other. In particular, reduced muscle mass and muscle function have been associated with poor quality of life and a worse course of disease. Sarcopenia is therefore becoming an increasingly important factor in various disease patterns and should be monitored further. Muscle atrophy and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly important in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, complex equipment and procedures are required for the measurements. Furthermore, radiological imaging is costly and causes radiation exposure. Therefore, attempts have been made in the past to simplify the measurements. Sonographic measurement is a practical alternative. Many different muscle groups are accessible to ultrasound. In particular, the thigh muscles and the psoas major muscle can be easily visualized using sonography. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches to bedside morphometry that we use primarily.

Currently, little is known about serological muscle parameters. Measurement in the blood would be more elegant than sonographic muscle measurement. This would save additional instrumental diagnostics and still provide an impression of the musculature and thus possibly of the patient's fitness. Various biomarkers come into question for this. In particular, markers of muscle protein synthesis such as activin A/B and myostatin have already been described in individual collectives. However, biomarkers require further research, especially in various disease entities.

The investigators expect sonographic and laboratory measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results during therapy.

Interventions

• Diagnostic test Ultrasound
  Sonographisch measurement of muscles Blood muscle markers

Primary outcome measures

• Complication [Time frame: 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]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

• patients incapable of consenting
• patients with congenital muscle diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• Universitatsmedizin Mainz — Mainz

Publications

• 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
• 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
• 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
• 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
• Hida T, Ando K, Kobayashi K, Ito K, Tsushima M, Kobayakawa T, Morozumi M, Tanaka S, Machino M, Ota K, Kanbara S, Ito S, Ishiguro N, Hasegawa Y, Imagama S. <Editors' Choice> Ultrasound measurement of thigh muscle thickness for assessment of sarcopenia. Nagoya J Med Sci. 2018 Nov;80(4):519-527. doi: 10.18999/nagjms.80.4.519. PMID 30587866
• 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. PMID 31547952
• Kobayashi K, Maruyama H, Kiyono S, Ogasawara S, Suzuki E, Ooka Y, Chiba T, Kato N, Yamaguchi T. Application of transcutaneous ultrasonography for the diagnosis of muscle mass loss in patients with liver cirrhosis. J Gastroenterol. 2018 May;53(5):652-659. doi: 10.1007/s00535-017-1378-2. Epub 2017 Aug 18. PMID 28821966
• 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

Identifiers

NCT: NCT06829290 · 2024-17561

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗