Observational Study About Patients Diagnosed With NAFLD

Recruiting

• Conditions: Nonalcoholic Fatty Liver Disease

• Registration Number: NCT05625750
• Lead Sponsor: Xiangya Hospital of Central South University

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common condition affecting the liver, owing to its association with obesity and the metabolic syndrome. The largest study to date using magnetic resonance spectroscopy to quantify liver triglyceride (TG) content showed that approximately 33% of individuals have hepatic steatosis. NAFLD encompasses a continuum of histological findings that starts with steatosis that can progress to nonalcoholic steatohepatitis (NASH), which is characterized by inflammation and cell death, and eventually cirrhosis. Given the large number of individuals afflicted with this condition, there is a clear need to develop effective and safe therapies to treat NAFLD.

Detailed Description

Patients with NAFLD were recruited in the current study and divided into NAFLD group, and NASH group. The researchers will collect various clinical examination indexes of the subjects in the process of diagnosis and treatment, including but not limited to ALT, AST, TG, TC, etc. Characteristic and prognosis of patients will be recorded. The serum, feces, urine and liver (if necessary) samples of all subjects will be taken after enrollment and stored for probably testing in the future. This study has no additional intervention and treatment for subjects.

Study Timeline

• Study Start: 2022-04-27
• Status Verified: 2022-11
• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Last Update Submitted: 2022-11-25
• Last Update Posted: 2022-11-30
• Primary Completion: 2025-04-27
• Study Completion: 2027-04-27

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. patients diagnosed with nonalcoholic fatty liver disease

Exclusion Criteria

1. patients suspected of excessive alcohol consumption
2. malignant tumors, dementia, active tuberculosis, AIDS, organ failure, pregnancy or breastfeeding, etc cannot cooperate with the investigation
3. incomplete data such as HBV serological results and abdominal ultrasound results
4. patients who refuse to sign informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BMI	3 weeks	BMI stands for body mass index. This is the ratio of a person's height to their weight.
alcohol intake	3 years	alcohol consumption every week

Trial Locations

Locations (1)

Department of Infectious Disease, Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China