Effects of beta-hydroxy-beta-methylbutyrate supplementation in decompensated cirrhosis patients with sarcopenia: Randomize controlled trial, Preliminary Study
- Conditions
- Decompensated cirrhosis is associated with poor outcomes, especially when combined with sarcopenia.Cirrhosis, Sarcopenia, Beta-hydroxy beta-methylbutyrate
- Registration Number
- TCTR20240422012
- Lead Sponsor
- Khon Kaen University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 23
1. Aged more than 18-years-old
2. Decompensated cirrhosis
cirrhosis includes either of the following criteria
- liver biopsy or
- history of complications related to cirrhosis, such as ascites, variceal bleeding, hepatic encephalopathy or
- meeting 2 out of 4 criteria of transient elastography > 13 kPa, radiological assessments showing features consistent with cirrhosis (enlarged liver, dilated portal veins, or the presence of ascites), APRI greater than 2.0, and EGD revealing signs of varices.
- Decompensated cirrhosis is defined by the presence or history of overt PHT-related bleeding, ascites of at least grade 2, overt hepatic encephalopathy, or a Child-Pugh score of B or C.
3. Sarcopenia
criteria by the Asian Working Group for Sarcopenia and the extended criteria of reduced muscle mass use a threshold in international criteria
1. active cancer
2. untreated chronic hepatitis B or C
3. alcohol consumption within the past 6 months
4. severe active infections
5. chronic kidney disease (CKD) stage 4 or 5
6. uncontrolled diabetes defined by HbA1C > 9%
7. active heart failure defined by New York Heart Association (NYHA) class III or IV
8. chronic obstructive pulmonary disease GOLD C or D
9. limitations for conducting bioelectrical impedance analysis (BIA) measurements presence of metal implants in the body, limb disability or amputation, pregnancy, use of a cardiac pacemaker or implantable cardiac resynchronization therapy
10. post-liver transplantation (LT) or LT waiting list
11. Eastern Cooperative Oncology Group (ECOG) performance status 3 or 4
12. ascites grade 3 or refractory ascites
13. recent spontaneous bacterial peritonitis or gastrointestinal bleeding, or hepatic encephalopathy within the last 3 months.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Muscle mass 12 week, 24 week bioelectrical impedance analysis (BIA)
- Secondary Outcome Measures
Name Time Method muscle performance ,muscle strength, body composition 12 week, 24 week bioelectrical impedance analysis (BIA),the rate of hospitalization, decompensated events, and mortality 12 week, 24 week questionnaire interview