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

Metabolic Associated Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04573283
• Other study ID #: NFEC-201506
• Status: Recruiting
• Start date: August 17, 2020
• Est. completion date: August 17, 2030

Study information

• Verified date: September 2020
• Source: Nanfang Hospital of Southern Medical University
• Contact: Jinjun Chen
• Phone: 8618588531001
• Email: chjj[@]smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: August 17, 2030
• Est. primary completion date: August 17, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.).

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Associated Fatty Liver Disease

Locations

Country	Name	City	State
China	Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	10 years
Primary	All cause death	Noticed death of patient at follow-up visit	10 years
Secondary	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	10 years
Secondary	The correlation between different metabolic components and the clinical manifestations and disease progression	Risks of developing liver-related complications and important extra-hepatic outcomes	10 years