Observational Study About Patients Diagnosed With NAFLD

Nonalcoholic Fatty Liver Disease Clinical Trial

Official title:

Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625750
• Other study ID #: Xiangya NAFLD project
• Status: Recruiting
• Start date: April 27, 2022
• Est. completion date: April 27, 2027

Study information

• Verified date: November 2022
• Source: Xiangya Hospital of Central South University
• Contact: Yan Huang
• Phone: +86 13874854142
• Email: ganrankedrhyan[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 27, 2027
• Est. primary completion date: April 27, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Nonalcoholic Fatty Liver Disease

Locations

Country	Name	City	State
China	Department of Infectious Disease, Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

Wang S, Zhu Q, Liang G, Franks T, Boucher M, Bence KK, Lu M, Castorena CM, Zhao S, Elmquist JK, Scherer PE, Horton JD. Cannabinoid receptor 1 signaling in hepatocytes and stellate cells does not contribute to NAFLD. J Clin Invest. 2021 Nov 15;131(22). pii: e152242. doi: 10.1172/JCI152242. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BMI	BMI stands for body mass index. This is the ratio of a person's height to their weight.	3 weeks
Primary	alcohol intake	alcohol consumption every week	3 years