Risk Factors and Prediction Model for Liver-Related Outcomes in Elderly Patients With Steatotic Liver Disease

Risk Factors and Prediction Model for Liver-Related Adverse Outcomes in Elderly Patients With Steatotic Liver Disease

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.

Study Overview

• Status: Completed
• Conditions: Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatotic Liver Disease

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.

• Study Type: Observational
• Enrollment (Actual): 10000

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population is derived from the Nanjing Elderly Steatotic Liver Disease Cohort, which includes individuals aged ≥60 years with imaging or biopsy-confirmed hepatic steatosis. Participants underwent annual health examinations from 2018 to March 2026. Data on demographics, lifestyle, anthropometrics, laboratory tests, abdominal ultrasound, and medication use were collected. All data were retrospectively extracted from medical records and the cohort database.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Elderly SLD Cohort; Elderly patients (aged ≥60 years) with steatotic liver disease (SLD) confirmed by imaging or biopsy, enrolled from the Nanjing Elderly Steatotic Liver Disease Cohort.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Significant Fibrosis	Significant fibrosis defined as FIB-4 ≥ 2.67. Occurrence during follow-up will be assessed.	From baseline (first eligible visit) up to study completion (March 2026), assessed annually

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Advanced Fibrosis	Advanced fibrosis defined as FIB-4 ≥ 3.25.	From baseline up to March 2026, assessed annually
Incidence of Cirrhosis	Cirrhosis diagnosed by imaging (ultrasound, CT, or MRI) or liver biopsy during follow-up.	From baseline up to March 2026, assessed annually
Incidence of Hepatocellular Carcinoma (HCC)	HCC diagnosed by imaging or histopathology according to clinical guidelines.	From baseline up to March 2026, assessed annually
Liver-Related Mortality	Death attributed to liver failure, complications of cirrhosis, or hepatocellular carcinoma.	From baseline up to March 2026, assessed annually
New-Onset Type 2 Diabetes Mellitus	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.	From baseline up to March 2026, assessed annually
New-Onset Chronic Kidney Disease (CKD)	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.	From baseline up to March 2026, assessed annually
Incidence of Cardiovascular and Cerebrovascular Events	Composite of nonfatal myocardial infarction, coronary revascularization, stroke, or cardiovascular death.	From baseline up to March 2026, assessed annually

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: April 12, 2026
• First Submitted That Met QC Criteria: April 12, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Elderly; Risk Factors; Prediction Model; Liver Fibrosis; Steatotic Liver Disease
• Additional Relevant MeSH Terms: Pathologic Processes; Digestive System Diseases; Liver Diseases; Fibrosis; Pathological Conditions, Signs and Symptoms; Liver Cirrhosis
• Other Study ID Numbers: IDD-2026-01 (Other Identifier: Nanjing Drum Tower Hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No