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OpenTrials
Completed

NCT Number: NCT05041348

Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Affiliated Hospital of Qingdao University

Qingdao, 266003, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • Patients aged between 18 and 60 years old
  • Patients with no history of drinking or abstinence for more than 1 year
  • Voluntary participants with informed consent

Exclusion criteria

  • 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

Treatment and study plan

CT at the level of the third lumbar vertebra (L3)

Diagnostic Test

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

Primary outcomes

  1. amino acids metabolism

    Time frame: 2021.09.01-2022.08.01

    Arginine biosynthesis, Phenylalanine, tyrosine and tryptophan biosynthesis were the enrichment pathway in two groups.

  2. central carbon metabolism

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Affiliated Hospital of Qingdao University

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 13, 2021
Registry last updated
Sep 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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