NCT04573283Recruiting
A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China
Source: ClinicalTrials.gov · Last updated 9 Feb 2021 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 3000 (estimated)
- First submitted
- 27 Sept 2020
- Start date
- 17 Aug 2020
- Primary completion date
- 17 Aug 2030
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT04573283
What you commit to
- Study type: Observational
- Planned participants: 3000
- From 17 Aug 2020 to the primary completion date, 17 Aug 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria);
- Patients with history of liver transplantation;
- Patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).
Other
- During pregnancy;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.