Clinical trial NCT05625750: Observational Study About Patients Diagnosed With NAFLD
Official title: Study on the Characteristic, Therapy and Prognosis of Patients With Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Nonalcoholic Fatty Liver Disease
Keywords: Nonalcoholic Fatty Liver Disease
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the age of 18-75, who was diagnosed with NAFLD were all elligible for this observational study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: BMI
timeFrame: 3 weeks
measure: alcohol intake
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Infectious Disease, Xiangya Hospital, Central South University
state: Hunan
Study officials:
affiliation: Xiangya Hospital of Central South University
name: Yan Huang
role: STUDY_DIRECTOR
References:
citation: 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):e152242. doi: 10.1172/JCI152242.