Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

Sarcopenia Clinical Trial

Official title:

Affiliated Hospital of Qingdao University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041348
• Other study ID #: QYFYWZLL26461
• Status: Completed
• Start date: August 17, 2021
• Est. completion date: August 17, 2022

Study information

• Verified date: September 2022
• Source: The Affiliated Hospital of Qingdao University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 17, 2022
• Est. primary completion date: July 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Diagnostic Test:
• CT at the level of the third lumbar vertebra (L3)
Muscle mass loss was defined as an skeletal muscle mass index (SMI) less than 46.96 cm²/m² for males and less than 32.46 cm²/m² for females

Locations

Country	Name	City	State
China	The Affiliated Hospital of Qingdao University	Qingdao

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of Qingdao University

Country where clinical trial is conducted

China, 

Outcome

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