UltrasoundNCT06829121
Ultrasound-based Morphometry for the Development of Diagnostic and Prognostic Markers in Current and Chronic Diseases
An observational study of Ultrasound and Sarcopenia, run by Universitatsmedizin Mainz - 1. Medizinische Klinik at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ultrasound, Sarcopenia, Muscle Loss
- What is being tested?
- Ultrasound
- How many people
- 900 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 1 Dec 2024
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Patients under 18 years of age.
- Patients unable to give consent.
- Patients with neuromuscular disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 stress factors. 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 wasting and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly noteworthy in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual-energy X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, the measurements require complex equipment and procedures. In addition, 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 sonographically. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches for bedside morphometry that the investigators use primarily.
Sarcopenia needs to be further investigated and included in the evaluation of therapeutic concepts. Recently, Zhang et al. showed that radiologically measured reduced psoas muscle mass was associated with poorer overall survival in HCC patients. Furthermore, it has been suggested several times that sarcopenia should be integrated into the MELD classification for liver transplantation. The investigators were also recently able to show in a cohort of COVID-19 patients that reduced muscle mass was associated with a poorer disease course during the pandemic.
The investigators expect sonographic measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results under therapy.
- Conditions
- Ultrasound, Sarcopenia, Muscle Loss
- Being tested
- Ultrasound
- Keywords
- muscle measurement by ultrasound, evaluation of muscle mass
- Medical subject headings
- Sarcopenia, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
The thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound patients | Patients who receive a standard ultrasound also get a measurement of the musculature. Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication
Number of participants with decompensation of the underlying disease (e.g. liver cirrhosis: hydropic decompensation) or death
Measured: From date of inclusion until the date of first documented decompensation or death from any cause, whichever came first, assessed up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start1 Oct 2020
- Primary completion20 May 2022
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for UltrasoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 900 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitatsmedizin Mainz - 1. Medizinische Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wolfgang Maximilian Kremer, Universitatsmedizin Mainz - 1. Medizinische Klinik
- Investigators
- Wolfgang Maximilian Kremer WMK Kremer, MD, Principal investigator, Universitatsmedizin Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829121
- Sponsor's protocol ID
- 2020-15174
- Status last verified
- Feb 2025
- First submitted
- 4 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be published as part of publications if necessary.
Publications
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.
PubMed 31547952Hida 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.
PubMed 30587866Takai 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.
PubMed 21448087McLean 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.
PubMed 24737560Benz 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.
PubMed 31722892Cruz-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.
PubMed 20392703Beaudart 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.
PubMed 28095426Xue 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.
PubMed 21093718
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-based Morphometry for the Development of Diagnostic and Prognostic Markers in Current and Chronic Diseases
- ClinicalTrials.gov ID
- NCT06829121
- Acronym / sponsor ID
- 2020-15174
- Conditions
- Ultrasound, Sarcopenia, Muscle Loss
- Keywords
- muscle measurement by ultrasound, evaluation of muscle mass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900 participants (actual)
- Lead sponsor
- Universitatsmedizin Mainz - 1. Medizinische KlinikUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 17 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 stress factors. 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 wasting and sarcopenia have multifactorial causes. Physical inactivity, chronic inflammation associated with chronic diseases, and malnutrition are particularly noteworthy in this context. Cross-sectional measurement of several muscles at the level of the lumbar vertebrae (L3), normalized to body size, and dual-energy X-ray absorptiometry are currently the most commonly used techniques for measuring sarcopenia. However, the measurements require complex equipment and procedures. In addition, 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 sonographically. The sonographic assessment of the psoas muscle area index (PMAI) and the thigh muscle thickness index (TMTI) are approaches for bedside morphometry that the investigators use primarily.
Sarcopenia needs to be further investigated and included in the evaluation of therapeutic concepts. Recently, Zhang et al. showed that radiologically measured reduced psoas muscle mass was associated with poorer overall survival in HCC patients. Furthermore, it has been suggested several times that sarcopenia should be integrated into the MELD classification for liver transplantation. The investigators were also recently able to show in a cohort of COVID-19 patients that reduced muscle mass was associated with a poorer disease course during the pandemic.
The investigators expect sonographic measurements of the musculature to provide a better assessment of prognosis, quality of life and functional results under therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound patients | – | Diagnostic Test: UltrasoundPatients who receive a standard ultrasound also get a measurement of the musculature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients under 18 years of age.
- Patients unable to give consent.
- Patients with neuromuscular disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundThe thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound | Diagnostic test | Ultrasound patients |
Primary outcome
Complication
Time frame: From date of inclusion until the date of first documented decompensation or death from any cause, whichever came first, assessed up to two years
Number of participants with decompensation of the underlying disease (e.g. liver cirrhosis: hydropic decompensation) or death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Results publication: PubMed 31547952Hari 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.
- Results publication: PubMed 30587866Hida 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.
- Results publication: PubMed 21448087Takai 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.
- Results publication: PubMed 24737560McLean 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.
- Results publication: PubMed 31722892Benz 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.
- Results publication: PubMed 20392703Cruz-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.
- Results publication: PubMed 28095426Beaudart 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.
- Results publication: PubMed 21093718Xue 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.
- Individual participant dataSharing planned: Undecided. The data will be published as part of publications if necessary.
Related trials for Ultrasound
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
Recruiting
Minimum Effective Local Anesthetic Volume for Ultrasound Guided Superior Trunk Block
Musculoskeletal Diseases or Conditions
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wolfgang Maximilian Kremer WMK Kremer, MD principal investigator
Universitatsmedizin Mainz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultrasound and Sarcopenia, run by Universitatsmedizin Mainz - 1. Medizinische Klinik at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication (time frame: From date of inclusion until the date of first documented decompensation or death from any cause, whichever came first, assessed up to two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06829121, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025.