Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Conditions
Brief summary
This longitudinal cohort study will enroll individuals with MASLD (and/or those at risk) and follow them over time to identify clinical and metabolic risk factors for disease progression and to evaluate predictors of long-term outcomes, including fibrosis progression and liver-related events, major cardiovascular events, and all-cause mortality.
Interventions
None listed
Sponsors
First Affiliated Hospital of Chongqing Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
Age 20 to 90 years at enrollment. Able and willing to provide written informed consent. Willing and able to comply with study assessments and follow-up for up to 2 years. Availability of baseline clinical evaluation and laboratory tests required by the protocol. For the MASLD cohort: Evidence of hepatic steatosis at baseline (e.g., imaging and/or noninvasive assessment) in the presence of metabolic dysfunction, consistent with contemporary MASLD criteria, and without alternative causes of steatosis per protocol. For the Control cohort: No evidence of MASLD/ hepatic steatosis at baseline (based on available imaging and/or noninvasive assessment), recruited from the same source population.
Exclusion criteria
Significant alcohol consumption exceeding protocol-defined thresholds. Known chronic liver diseases other than MASLD (including but not limited to chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, or alpha-1 antitrypsin deficiency). History of hepatocellular carcinoma, liver transplantation, or other active malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ) that may interfere with follow-up. Decompensated liver disease at baseline (e.g., ascites, variceal bleeding, hepatic encephalopathy) if not intended to be included per protocol. Use of medications known to cause hepatic steatosis or steatohepatitis (e.g., amiodarone, methotrexate, systemic corticosteroids, tamoxifen) within a protocol-defined period, if judged to be the primary cause of steatosis. Pregnancy or breastfeeding at enrollment (if applicable to your protocol assessments). Any serious medical condition or psychiatric disorder that, in the investigator's opinion, would make participation unsafe or interfere with study assessments or follow-up.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrosis progression (noninvasive) | Baseline to 2 years. | Change in liver fibrosis stage/risk assessed by transient elastography (liver stiffness measurement, LSM) and/or validated fibrosis scores (e.g., FIB-4, NAFLD Fibrosis Score). |
| Composite liver-related clinical events | Baseline to 2 years. | Incidence of liver-related events (composite), including hepatic decompensation (ascites, variceal bleeding, hepatic encephalopathy), new diagnosis of cirrhosis, hepatocellular carcinoma, liver transplantation, or liver-related death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steatosis change | Baseline to 2 years. | Change in hepatic steatosis assessed by CAP (controlled attenuation parameter) and/or imaging (ultrasound/CT/MRI-PDFF if available). |
| Liver enzymes improvement/worsening | Baseline to 2 years. | Change in ALT and AST levels. |
Countries
China
Contacts
STUDY_CHAIRXuesong Doctor
First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed