Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062415) titled 'Study of muscle, fat, handgrip strength, and health outcomes in patients with cirrhosis' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - Iwate Medical University School of Medicine
Condition:
Condition - Cirrhosis
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - The aim of this study is to clarify the sex-specific impact of body composition and handgrip strength on prognosis in patients with liver cirrhosis. Specifically, visceral adipose tissue, subcutaneous adipose tissue, handgrip strength, and skeletal muscle mass will be analyzed as continuous variables, and restricted cubic spline (RCS) analysis will be used to characterize nonlinear associations with prognosis in each sex.
Basic objectives2 - Others
Eligibility:
Age-lower limit - 40
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients with liver cirrhosis who had available data on body composition assessed at the third lumbar vertebra (L3) level using abdominal CT and handgrip strength, and who had at least 1 year of follow-up after the body composition assessment.
Key exclusion criteria - Patients with malignant tumors, including hepatocellular carcinoma, at the time of body composition assessment (baseline).
Patients with renal failure or poorly controlled cardiac or respiratory disease at the time of body composition assessment (baseline).
Patients with missing data required for the analysis.
Patients who declined participation in the study through the opt-out process.
Target Size - 1000
Recruitment Status:
Recruitment status - No longer recruiting
Date of protocol fixation - 2026 Year 02 Month 02 Day
Date of IRB - 2026 Year 04 Month 14 Day
Anticipated trial start date - 2026 Year 04 Month 15 Day
Last follow-up date - 2027 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071426
Disclaimer: Curated by HT Syndication.