Metabonomic of Patients With Hepatitis B Cirrhosis Complicated With Sarcopenia.

NCT ID: NCT05041348

Last Updated: 2022-09-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-08-17
• Study Completion Date: 2022-08-17

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.

Conditions

Sarcopenia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

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

Intervention Type: 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

liver cirrhosis patients with normal muscle mass

Skeletal muscle mass index (SMI) was not decreased in this group.

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

Intervention Type: 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

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.

No interventions assigned to this group

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Affiliated Hospital of Qingdao University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Affiliated Hospital of Qingdao University

Qingdao, , China

Countries

China

Other Identifiers

QYFYWZLL26461

Identifier Type: -

Identifier Source: org_study_id