Clinical trial NCT04573283: A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China
Official title: A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Metabolic Associated Fatty Liver Disease
Keywords: metabolic associated fatty liver disease
metabolic
nonalcoholic fatty liver disease (NAFLD)
non-MR-NAFLD
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study include 3000 patients diagnosed as hepatic steatosis (both inpatients and outpatients of Nanfang hospital). We exclude the patients with history of liver transplantation, history of hepatocellular carcinoma (HCC) or other active malignancy, congestive heart failure and serious cerebrovascular disease, and pregnancy.

Brief summary: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a new concept proposed in 2020. Unlike non-alcoholic fatter liver disease (NAFLD), the diagnosis of MAFLD requires the presence any of the following 3 metabolic risks, including overweight/obesity, presence of diabetes mellitus, and evidence of metabolic dysregulation. However, there are patients that have hepatic steatosis but no metabolic risk, who thus do not meet the diagnostic criteria of MAFLD. Besides, there are patients with both MAFLD and other liver diseases. The clinical features and the management of these patients remain unclear. Thus, further histopathological and clinical study is required to elucidate and compare the characteristics of MAFLD and NAFLD.

Here, in this single-center, prospective clinical study, investigators are planning to establish a long-term follow-up cohort of patients with either MAFLD or NAFLD. In order to understand the risk of developing liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease), and also to better elucidate the risk of disease progression in "lean" NAFLD individuals without any metabolic dysregulation and MAFLD individuals with dual or multiple causes.

Ultimately, investigators aim to improve the diagnosis of MAFLD and improve patients' outcomes.

Detailed description: The study is divided into 2 parts:

Firstly, it contains a cross-sectional study to collect the clinical data of the patients with fatty liver. The clinical features of this population will be analysed.

Secondly, the study will collect the plasma, urine and stool samples of the patients in this cohort. And then a long-term follow-up of these patients will be carried out. Investigators wish to find out biomarkers that can detail patient stratification and predict the prognosis of the disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as hepatic steatosis in adults (fulfill at least one of the followings):

  1. Liver ultrasound shows liver parenchymal hyperechoic or "bright liver"
  2. Controlled attenuation-parameter (CAP) ≥248dB/m
  3. Hepatic steatosis diagnosed by CT/MRI/MRS
  4. MRI-based proton-density fat fraction (MRI-PDFF) shows liver fat content\>8%
  5. Fatty liver confirmed by liver histology.

Exclusion Criteria:

1. Diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria);
2. During pregnancy;
3. Patients with history of liver transplantation;
4. Patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).

Primary outcomes:
measure: All cause death
timeFrame: 10 years
Secondary outcomes:
measure: Liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease)
timeFrame: 10 years
measure: The correlation between different metabolic components and the clinical manifestations and disease progression
timeFrame: 10 years
Other outcomes:
measure: The clinical manifestations and differences of metabolic-related fatty liver disease combine with different liver diseases
timeFrame: 10 years
Locations:
city: Guangzhou
country: China
facility: Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
References: