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NCT Number: NCT04573283

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.

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Key information

Conditions

Metabolic Associated Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed as hepatic steatosis in adults (fulfill at least one of the followings):
  • 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%
  • Fatty liver confirmed by liver histology.

Exclusion criteria

  • 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.).

Treatment and study plan

Primary outcomes

  1. All cause death

    Time frame: 10 years

    Noticed death of patient at follow-up visit

Secondary outcomes

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

    Time frame: 10 years

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

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

    Time frame: 10 years

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

Other outcomes

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

    Time frame: 10 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jinjun Chen

CONTACT

[email protected]

8618588531001

Ling Zhou

CONTACT

[email protected]

8613631383539

Sponsors and collaborators

Lead sponsor

Nanfang Hospital, Southern Medical University

Other

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Oct 5, 2020
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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