Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

Completed

• Conditions: Sarcopenia
• Interventions: Diagnostic Test: CT at the level of the third lumbar vertebra (L3)

• Registration Number: NCT05041348
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

Sarcopenia is a common complication in liver cirrhosis patients and has been confirmed that associated with poor prognosis. China has the world's largest burden of hepatitis B virus-related liver cirrhosis (HBV-related liver cirrhosis). However, the relationship between HBV-related liver cirrhosis patients with muscle mass loss and normal muscle mass is remain largely unknown. Our study aimed to reveal the metabolic profile and identify potential biomarkers of muscle mass loss in HBV-related liver cirrhosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-15
• Study Start: 2021-08-17
• Study First Submitted QC: 2021-09-02
• Study First Posted: 2021-09-13
• Primary Completion: 2022-07-15
• Study Completion: 2022-08-17
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-13
• Last Update Posted: 2022-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. the diagnostic criteria for decompensation of liver cirrhosis of chronic viral hepatitis B formulated according to the Guidelines for Diagnosis and Treatment of Liver Cirrhosis issued by the Chinese Society of Hepatology in 2019
2. The diagnosis of muscle mass loss conforms to SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females
3. Patients aged between 18 and 60 years old
4. Patients with no history of drinking or abstinence for more than 1 year
5. Voluntary participants with informed consent

Exclusion Criteria

1. the etiology of cirrhosis without hepatitis B virus (HBV), such as cirrhosis, alcoholic cirrhosis, autoimmune cirrhosis, and so on; 2) the age of patients over 60 years old; 3) patients with acute, chronic and acute liver failure; 4) other diseases which can lead to the secondary muscle depletion, such as chronic disease in heart, lung, kidney, brain, and malignant tumor; 5) neurodegenerative diseases or muscle degenerative diseases; 6) perioperative patients; 7) patients without CT scan within 3 months; 8) patients who have exercise habits with the Physical Activity Rating Scale-3 (PARS-3) > 19 points

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
liver cirrhosis patients with normal muscle mass	CT at the level of the third lumbar vertebra (L3)	Skeletal muscle mass index (SMI) was not decreased in this group.
liver cirrhosis patients with muscle mass loss	CT at the level of the third lumbar vertebra (L3)	The diagnosis of cirrhosis was made based on the combination of clinical and laboratory features or by liver histopathology. Skeletal muscle mass index (SMI), which was the ratio of lean tissue area to body height. Muscle mass loss was defined as an SMI less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females

Primary Outcome Measures

Name	Time	Method
amino acids metabolism	2021.09.01-2022.08.01	Arginine biosynthesis, Phenylalanine, tyrosine and tryptophan biosynthesis were the enrichment pathway in two groups.
central carbon metabolism	2021.09.01-2022.08.01	D-fructose-6-phosphate,L-glutamic acid, and Fumaric acid were selected as differential metabolites in pathway of central carbon metabolism.

Trial Locations

Locations (1)

The Affiliated Hospital of Qingdao University; 🇨🇳 Qingdao, China