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临床试验/NCT05041348
NCT05041348已完成不适用

Affiliated Hospital of Qingdao University

The Affiliated Hospital of Qingdao University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2021年8月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
amino acids metabolism

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

amino acids metabolism

时间窗: 2021.09.01-2022.08.01

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

central carbon metabolism

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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