Metabolic Dysfunction-Associated Steatotic Liver Disease, Steatotic Liver Disease
Conditions
Keywords
Steatotic Liver Disease, Elderly, Risk Factors, Prediction Model, Liver Fibrosis
Brief summary
This is a single-center, retrospective cohort study based on data from the Nanjing Elderly Steatotic Liver Disease Cohort. The study aims to investigate risk factors for liver-related adverse outcomes (including significant fibrosis, advanced fibrosis, cirrhosis, hepatocellular carcinoma, and liver-related death) and extrahepatic outcomes (new-onset type 2 diabetes, chronic kidney disease, and cardiovascular disease) in elderly patients (aged ≥60 years) with steatotic liver disease. A total of approximately 10,000 participants will be included. Baseline and annual follow-up data on demographics, lifestyle, anthropometric measurements, laboratory tests, abdominal ultrasound, and medication use will be collected. Risk prediction models will be developed using machine learning algorithms. The study is observational and does not involve any intervention.
Detailed description
Background: Steatotic liver disease (SLD) is highly prevalent among the elderly and can progress to cirrhosis and hepatocellular carcinoma. However, large-scale longitudinal studies focusing on risk prediction in Chinese elderly populations are limited. Objectives: Primary objective is to identify risk factors and develop a prediction model for significant fibrosis. Secondary objectives include models for advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes (type 2 diabetes, chronic kidney disease, cardiovascular disease), as well as comparison of outcomes across SLD subtypes (MASLD, MetALD, ALD). Methods: This is a single-center, retrospective cohort study using data from the Nanjing Elderly Steatotic Liver Disease Cohort (initiated in 2018). Approximately 10,000 participants aged ≥60 years with imaging or biopsy-proven hepatic steatosis will be included. Baseline and annual follow-up data include demographics, lifestyle factors (smoking, alcohol, diet, physical activity), anthropometric measurements, laboratory tests (glucose, lipids, liver and kidney function), abdominal ultrasound, and medication use. The primary outcome is significant fibrosis (FIB-4 ≥2.67); secondary outcomes include advanced fibrosis, cirrhosis, hepatocellular carcinoma, liver-related death, and extrahepatic outcomes. Cox regression will be used for univariate and multivariate analyses. Machine learning algorithms (random forest, XGBoost, Cox-boost) will be applied to develop prediction models, with performance evaluated by time-dependent ROC curves, calibration curves, and decision curve analysis. A competing risk model will account for death as a competing event. The study has been approved by the Ethics Committee of the Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Interventions
None listed
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥60 years * Presence of hepatic steatosis confirmed by baseline imaging (e.g., ultrasound, transient elastography) or liver biopsy
Exclusion criteria
* Missing data for key variables * Pre-existing hepatocellular carcinoma or history of liver transplantation at baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Significant Fibrosis | From baseline (first eligible visit) up to study completion (March 2026), assessed annually | Significant fibrosis defined as FIB-4 ≥ 2.67. Occurrence during follow-up will be assessed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Advanced Fibrosis | From baseline up to March 2026, assessed annually | Advanced fibrosis defined as FIB-4 ≥ 3.25. |
| Incidence of Cirrhosis | From baseline up to March 2026, assessed annually | Cirrhosis diagnosed by imaging (ultrasound, CT, or MRI) or liver biopsy during follow-up. |
| Incidence of Hepatocellular Carcinoma (HCC) | From baseline up to March 2026, assessed annually | HCC diagnosed by imaging or histopathology according to clinical guidelines. |
| Liver-Related Mortality | From baseline up to March 2026, assessed annually | Death attributed to liver failure, complications of cirrhosis, or hepatocellular carcinoma. |
| New-Onset Type 2 Diabetes Mellitus | From baseline up to March 2026, assessed annually | Defined as fasting glucose ≥126 mg/dL (7.0 mmol/L) or HbA1c ≥6.5% (48 mmol/mol) or initiation of glucose-lowering medication during follow-up. |
| New-Onset Chronic Kidney Disease (CKD) | From baseline up to March 2026, assessed annually | Defined as estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m² or urine albumin-to-creatinine ratio ≥30 mg/g on two consecutive measurements. |
| Incidence of Cardiovascular and Cerebrovascular Events | From baseline up to March 2026, assessed annually | Composite of nonfatal myocardial infarction, coronary revascularization, stroke, or cardiovascular death. |
Countries
China
Outcome results
None listed