Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632743
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
Austrian Biobanking Study for Sarcopenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Sarcopenia in Cirrhosis and Chronic Inflammatory Bowel Disease An Austrian Biobanking Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASGSC
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 fallsThe 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 flexionextension 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
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 flexionextension 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None