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NCT Number: NCT07537829

Risk Factors and Prediction Model for Liver-Related 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.

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Key information

Conditions

Steatotic Liver Disease Digestive System Diseases Fibrosis Liver Cirrhosis Liver Diseases Metabolic Dysfunction-Associated Steatotic Liver Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University

Nanjing, Jiangsu, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Incidence of Significant Fibrosis

    Time frame: 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 outcomes

  1. Incidence of Advanced Fibrosis

    Time frame: From baseline up to March 2026, assessed annually

    Advanced fibrosis defined as FIB-4 ≥ 3.25.

  2. Incidence of Cirrhosis

    Time frame: From baseline up to March 2026, assessed annually

    Cirrhosis diagnosed by imaging (ultrasound, CT, or MRI) or liver biopsy during follow-up.

  3. Incidence of Hepatocellular Carcinoma (HCC)

    Time frame: From baseline up to March 2026, assessed annually

    HCC diagnosed by imaging or histopathology according to clinical guidelines.

  4. Liver-Related Mortality

    Time frame: From baseline up to March 2026, assessed annually

    Death attributed to liver failure, complications of cirrhosis, or hepatocellular carcinoma.

  5. New-Onset Type 2 Diabetes Mellitus

    Time frame: 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.

  6. New-Onset Chronic Kidney Disease (CKD)

    Time frame: 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.

  7. Incidence of Cardiovascular and Cerebrovascular Events

    Time frame: From baseline up to March 2026, assessed annually

    Composite of nonfatal myocardial infarction, coronary revascularization, stroke, or cardiovascular death.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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