Understanding Metabolic Associated Fatty Liver Disease in China
A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China
Nanfang Hospital, Southern Medical University · NCT04573283
This study is trying to learn more about metabolic liver disease in China by collecting health information and samples from patients to find markers that could help predict how the disease affects them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3000 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University (other) |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04573283 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a long-term cohort of patients diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) or non-alcoholic fatty liver disease (NAFLD) in China. It will involve a cross-sectional analysis to collect clinical data and a follow-up to gather plasma, urine, and stool samples from participants. The goal is to identify biomarkers that can help in patient stratification and predict disease prognosis, thereby enhancing understanding of liver-related complications associated with these conditions.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with hepatic steatosis based on specific imaging or histological criteria.
Not a fit: Patients with hepatocellular carcinoma, other malignancies, or serious cardiovascular events will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and management strategies for patients with fatty liver diseases.
How similar studies have performed: While the concept of MAFLD is relatively new, similar studies on NAFLD have shown promise in understanding liver diseases, indicating potential for success in this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Guangzhou, Guangdong
- Hepatology Unit, Department of Infectious Diseases, Nanfang Hospital, Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)
Study contacts
- Study coordinator: Jinjun Chen
- Email: chjj@smu.edu.cn
- Phone: 8618588531001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metabolic Associated Fatty Liver Disease, metabolic associated fatty liver disease, metabolic, nonalcoholic fatty liver disease, non-MR-NAFLD