Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345547
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-14
Brief Title:
Muscle Mass Via UltraSound in Cirrhosis MMUSCLE
Sponsor:
University Hospital Antwerp
Organization:
University Hospital Antwerp
Study Overview
Official Title:
Prospective Observational Cohort Survey to Assess the Prevalence and Development of Sarcopenia and the Correlation of Muscle Mass and Outcome in Patients With Cirrhosis by Skeletal Muscle Ultrasound
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MMUSCLE
Brief Summary:
The goal of this observational cohort study is to learn about loss of muscle mass and muscle strength sarcopenia in patients with cirrhosis The main questions it aims to answer are
what is the prevalence and development of sarcopenia in cirrhosis
what is the role of malnutrition Participants will
undergo a muscle ultrasound of the lower and upper limb muscles
handgrip strength will be measured
malnutrition screening and assessment
complete a questionnaire to assess quality of life
what is the prevalence and development of sarcopenia in cirrhosis
what is the role of malnutrition Participants will
undergo a muscle ultrasound of the lower and upper limb muscles
handgrip strength will be measured
malnutrition screening and assessment
complete a questionnaire to assess quality of life
Detailed Description:
In this study the investigators will assess the prevalence and development of sarcopenia in the large in- and outpatient population with cirrhosis n 1346 of the University Hospital of Antwerp using ultrasound assessment of muscle mass and quality in the lower as well as the upper limb muscles Handgrip strength will be tested for muscle functional status Findings will be correlated with clinical outcome MELD survival decompensating events The etiology of the cirrhosis and its underlying activity will be taken into account as dependent variables eg whether there is a difference between compensated vs decompensated cirrhosis The investigators will screen for malnutrition using the RFH-NPT and compare with the GLIM criteria The effect of sarcopenia on the quality of life will be evaluated using the validated SarQoL Sarcopenia Quality of Life questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None