NCT04573283 A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China
| NCT ID | NCT04573283 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Metabolic Associated Fatty Liver Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 3,000 participants |
| Start Date | 2020-08-17 |
| Primary Completion | 2030-08-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 3,000 participants in total. It began in 2020-08-17 with a primary completion date of 2030-08-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04573283 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Metabolic Associated Fatty Liver Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04573283 currently recruiting?
Yes, NCT04573283 is actively recruiting participants. Contact the research team at chjj@smu.edu.cn for enrollment information.
Where is the NCT04573283 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04573283 clinical trial?
NCT04573283 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 3,000 participants.