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Recruiting NCT06632743

Austrian Biobanking Study for Sarcopenia

Observational Sarcopenia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Sarcopenia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Sarcopenia in Cirrhosis and Chronic Inflammatory Bowel Disease: An Austrian Biobanking Study

Overview

The investigators aim to set up a biobanking study in Graz, Austria, to study sarcopenia in liver cirrhosis and chronic inflammatory bowel disease by collecting a standardized dataset including routine clinical and biochemical tests; biosamples to assess novel biomarker as well as advanced clinical assessments. In a small country like Austria, a nationwide biobanking study can enhance research enormously. The investigators therefore aim to extend the registry to all tertiary liver care centers in Austria in a second step.

Detailed description

As the average age of societies rises, so too does the onset of debilitating diseases. Among these, sarcopenia, which is defined as a progressive decline in muscle mass, quality and strength, affects over one third and of people above 70 and half of patients with chronic diseases- such as liver cirrhosis or chronic inflammatory bowel disease (IBD). Sarcopenia remains an unmet clinical need with wide reaching implications affecting patients, their families and the health care system as a whole whereby patients lose independence due to their frailty which consequently decreases overall life quality and increases the risk of severe injuries, and complication thereof, due to falls.The pathogenesis of sarcopenia in cirrhosis is incompletely understood: Decreased protein synthesis and increased protein degradation mediated by inflammation contribute to sarcopenia in cirrhosis. In chronic inflammatory bowel disease, sarcopenia often results from a complex interplay of various factors, including inflammation, malabsorption, limited physical activity, and nutrient deficiencies.

Despite the high prevalence of sarcopenia among the aging and diseased populations, its diagnosis remains challenging as generally accepted international standards are lacking. Combined with the low agreement of available diagnosis criteria, this further complicates diagnostic methods. (8) To date, the diagnosis of sarcopenia relies on the quantification of muscle mass and a clinical assessment of muscle strength. For the estimation of muscle mass, costly computed tomography (CT) or magnetic resonance imaging (MRI) are the methods of choice to quantify the muscled area of a cross section on the level of the L3 vertebra- these methods also require skilled personnel and specialized software solutions for image evaluation. Methods used to assess muscle function, such as hand grip strength, gait speed and knee flexion/extension also require skilled personnel and present an additional layer of complexity to the overall diagnosis as they are difficult to standardize and heavily dependent patient compliance. Furthermore, the interpretation of the outlined diagnostic measures remains ambiguous, since different consensus definitions show conflicting results in different patient populations. Biomarker of muscle function and inflammation, as well as hormone assessments have been considered as useful diagnostic alternatives, however they are not part of clinical routine yet. Taken together, current diagnostic options for sarcopenia remain grossly insufficient which, often, allows this detrimental condition to be missed in clinical practice thereby hindering adequate and timely intervention.

In addition, currently there is no medical treatment available for sarcopenia. The current recommendation therefore is to improve nutrition, especially regarding the protein content, and physical activity.

Acquiring large enough datasets is of utmost importance to validate diagnostic tools or develop novel biomarker and therapies.

Primary outcome measures

  • Austrian-wide sarcopenia register [Time frame: At enrolment]

Eligibility criteria

Inclusion criteria

  • Age >18y
  • Informed consent
  • CT/MRI scan as part of routine care within +/-2 month of the study visit

Exclusion criteria

  • Hepatic encephalopathy > grade 2 and or other cognitive disorder not allowing informed consent
  • Hepatocellular carcinoma stage BCLC C or D
  • Any other condition or circumstance, which, in the opinion of the investigator, would affect the patient's ability to participate in the protocol

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

Austria · 1 center
  • Medical University of Graz — Graz

Identifiers

NCT: NCT06632743 · 34-294 ex 21/22

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗