Clinical trial NCT06632743: Austrian Biobanking Study for Sarcopenia
Official title: Sarcopenia in Cirrhosis and Chronic Inflammatory Bowel Disease: An Austrian Biobanking Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Keywords: Register
Biosamples
Microbiome
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-10-09
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical/radiological/histological diagnosis of cirrhosis or chronic liver disease or histological diagnose of chronic inflammatory bowel disease

Brief summary: 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.

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

Primary outcomes:
measure: Austrian-wide sarcopenia register
timeFrame: At enrolment
Secondary outcomes:
Other outcomes:
measure: Diagnostic accuracy
timeFrame: At enrolment
measure: Cut off definition
timeFrame: At enrolment
measure: AI (artificial intelligence) guided sarcopenia diagnosis
timeFrame: At enrolment
measure: Hypothesis generation
timeFrame: At enrolment
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References: