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

NCT04573283 · tracked via the Priya Life Science China tracker

Sponsor

Nanfang Hospital, Southern Medical University

Phase

Observational

Started

2020-08-17

Last updated

2021-02-09

Condition(s) studied

Metabolic Associated Fatty Liver Disease

Study 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

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

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.).

Primary outcome measure(s)

All cause death — 10 years
Noticed death of patient at follow-up visit

Trial sites (1)

Facility	City	Region	Status
Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong	Recruiting

More Nanfang Hospital, Southern Medical University trials in China

Efficacy and Safety of Indobufen, Aspirin, Cilostazol and Clopidogrel in the Treatment of Ischemic Stroke Starting soon

Adaptive Adjuvant Therapy After Neoadjuvant Therapy and Gastrectomy for Gastric or Gastroesophageal Junction Adenocarcinoma Starting soon

nVNS for the Prevention and Treatment of Primary Headache Recruiting

Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis Recruiting

The Outcome of Chronic Kidney Disease Patients With Obstructive Sleep Apnea Syndrome Recruiting

Other trials for the same condition

Prevalence of MAFLD in Patients With Type 2 Diabetes in Jiangsu Province of China Recruiting

Effect of Low Valine Diet on Body Weight and Metabolic Parameters Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04573283 on ClinicalTrials.gov ↗ ← All trials in China