A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorNanfang Hospital, Southern Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Liver ultrasound shows liver parenchymal hyperechoic or "bright liver"

Controlled attenuation-parameter (CAP) ≥248dB/m

Hepatic steatosis diagnosed by CT/MRI/MRS

MRI-based proton-density fat fraction (MRI-PDFF) shows liver fat content>8%

Disqualifiers

Diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria);

During pregnancy;

Patients with history of liver transplantation;

Patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed