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NCT Number: NCT06829290

Influence of Sarcopenia on the Course of the Diseases

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitatsmedizin Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location status: Recruiting

Location contact

Wolfgang Maximilian Kremer WMK Kremer, MD

CONTACT

[email protected]

00496131177134

Wolfgang Maximilian Kremer WMK Kremer, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Diagnostic Test

Sonographisch measurement of muscles Blood muscle markers

Primary outcomes

  1. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Christian Labenz Labenz, MD

CONTACT

0049 6131174209

Wolfgang Maximilian Kremer Kremer, MD

CONTACT

[email protected]

00496131175711

Sponsors and collaborators

Lead sponsor

Universitatsmedizin Mainz - 1. Medizinische Klinik

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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