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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Associated Fatty Liver Disease

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.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510515
      • Recruiting
      • Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause death	Noticed death of patient at follow-up visit	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 17, 2020
• Primary Completion (ANTICIPATED): August 17, 2030
• Study Completion (ANTICIPATED): August 17, 2030

Study Registration Dates

• First Submitted: September 27, 2020
• First Submitted That Met QC Criteria: September 27, 2020
• First Posted (ACTUAL): October 5, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 4, 2021
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: metabolic; metabolic associated fatty liver disease; nonalcoholic fatty liver disease (NAFLD); non-MR-NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NFEC-201506

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No