Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

Affiliated Hospital of Qingdao University

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.

Study Overview

• Status: Completed
• Conditions: Sarcopenia
• Intervention / Treatment: Diagnostic test: CT at the level of the third lumbar vertebra (L3)

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• China
  • Qingdao, China, 266003
    • The Affiliated Hospital of Qingdao University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with HBV-related liver cirrhosis were recruited between August 2021 and June 2022 at the Affiliated hospital of Qingdao University. All of the patients are in the decompensation stage of hepatitis B cirrhosis and divided them into two groups. One group is named cirrhosis with muscle mass loss, the other group is named liver cirrhosis with normal muscle mass. People in healthy control group were excluded metabolic diseases. Each group of patients is about 20.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
liver cirrhosis patients with muscle mass loss; 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	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
liver cirrhosis patients with normal muscle mass; Skeletal muscle mass index (SMI) was not decreased in this group.	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
healthy group; People in healthy control group were excluded metabolic diseases (including diabetes, thyroid disorder, and so on) and other chronic diseases, according to their ultrasound and laboratory assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amino acids metabolism	Arginine biosynthesis, Phenylalanine, tyrosine and tryptophan biosynthesis were the enrichment pathway in two groups.	2021.09.01-2022.08.01
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

Collaborators and Investigators

• Sponsor: The Affiliated Hospital of Qingdao University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2021
• Primary Completion (Actual): July 15, 2022
• Study Completion (Actual): August 17, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: metabolites; Hepatitis B virus-related liver cirrhosis; muscle mass loss
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: QYFYWZLL26461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No