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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University
RECRUITING
Guangzhou
Contact Information
Primary
Jinjun Chen
chjj@smu.edu.cn
8618588531001
Backup
Ling Zhou
vzhouling3168@163.com
8613631383539
Time Frame
Start Date: 2020-08-17
Estimated Completion Date: 2030-08-17
Participants
Target number of participants: 3000
Related Therapeutic Areas
Sponsors
Leads: Nanfang Hospital, Southern Medical University

This content was sourced from clinicaltrials.gov