Ultrasound-based Morphometry for the Development of Diagnostic and Prognostic Markers in Current and Chronic Diseases

NCT06829121 | Completed

• 1 other identifier: 2020-15174
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

Frailty or debility 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 component 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 require further validation. The aim of this project is to be able to estimate the prognosis of patients at an early stage by measuring sarcopenia using sonography.

Conditions

Ultrasound; Sarcopenia; Muscle Loss

Keywords

muscle measurement by ultrasound; evaluation of muscle mass

Outcome Measures

Primary Outcomes (1)

• Complication

  Number of participants with decompensation of the underlying disease (e.g. liver cirrhosis: hydropic decompensation) or death

  From date of inclusion until the date of first documented decompensation or death from any cause, whichever came first, assessed up to two years

Study Arms (1)

Ultrasound patients

Patients who receive a standard ultrasound also get a measurement of the musculature.

Diagnostic Test: Ultrasound

Interventions

Ultrasound DIAGNOSTIC_TEST

The thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound

Ultrasound patients

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

The study population consists of patients treated at the First Medical Clinic of the University Medical Center in Mainz who are scheduled to undergo a planned ultrasound examination.

You may qualify if:

• All patients who receive a planned ultrasound examination as part of their outpatient or inpatient evaluation during the planned period.
• All patients over 18 years of age.

You may not qualify if:

• Patients under 18 years of age.
• Patients unable to give consent.
• Patients with neuromuscular disorders.

Sponsors & Collaborators

• Universitatsmedizin Mainz - 1. Medizinische Klinik: lead

Study Sites (1)

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

• 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

• 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.

  PMID: 20392703 BACKGROUND

• Beaudart C, Zaaria M, Pasleau F, Reginster JY, Bruyere O. Health Outcomes of Sarcopenia: A Systematic Review and Meta-Analysis. PLoS One. 2017 Jan 17;12(1):e0169548. doi: 10.1371/journal.pone.0169548. eCollection 2017.

  PMID: 28095426 BACKGROUND

• Xue QL. The frailty syndrome: definition and natural history. Clin Geriatr Med. 2011 Feb;27(1):1-15. doi: 10.1016/j.cger.2010.08.009.

  PMID: 21093718 BACKGROUND

MeSH Terms

Conditions

Sarcopenia; Muscular Atrophy

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Wolfgang Maximilian Kremer WMK Kremer, MD

  Universitatsmedizin Mainz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• 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, 2020
• Primary Completion: May 20, 2022
• Study Completion: December 1, 2024
• Last Updated: February 17, 2025

Record last verified: 2025-02

Locations

DE (1)