NCT04573283

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,000 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Metabolic Associated Fatty Liver Disease

Timeline

• Start date: 2020-08-17
• Primary completion: 2030-08-17
• Completion: 2030-08-17
• First posted: 2020-10-05
• Last updated: 2021-02-09

Locations

1 site across 1 country: China