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

ConditionMetabolic Associated Fatty Liver Disease

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

This trial does not accept healthy volunteers

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 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

All cause death

Noticed death of patient at follow-up visit

Time frame

10 years

Secondary outcomes

Liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease)

Noticed liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease) of patient at follow-up visit

Time frame

10 years

The correlation between different metabolic components and the clinical manifestations and disease progression

Risks of developing liver-related complications and important extra-hepatic outcomes

Time frame

10 years

Other outcomes

The clinical manifestations and differences of metabolic-related fatty liver disease combine with different liver diseases

the clinical manifestations and long-term prognosis MAFLD with multiple or dual causes

Time frame

10 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nanfang Hospital, Southern Medical University

Lead sponsor

Source ClinicalTrials.gov

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