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

February 10, 2025 updated by: Wolfgang Maximilian Kremer, Universitatsmedizin Mainz - 1. Medizinische Klinik

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

900

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Germany, 55131
        • Universitatsmedizin Mainz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound patients
Patients who receive a standard ultrasound also get a measurement of the musculature.
Diagnostic test: Ultrasound
The thickness of the psoas muscle and the musculus quadriceps femoris will be measured by ultrasound

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitatsmedizin Mainz - 1. Medizinische Klinik

Investigators

  • Principal Investigator: Wolfgang Maximilian Kremer WMK Kremer, MD, Universitatsmedizin Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

May 20, 2022

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

February 4, 2025

First Submitted That Met QC Criteria

February 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 10, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-15174

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data will be published as part of publications if necessary.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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