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

NCT07537829 | Completed

• 1 other identifier: IDD-2026-01
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Steatotic Liver Disease; Metabolic Dysfunction-Associated Steatotic Liver Disease

Keywords

Steatotic Liver Disease; Elderly; Risk Factors; Prediction Model; Liver Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Incidence of Advanced Fibrosis

  From baseline up to March 2026, assessed annually

• Incidence of Cirrhosis

  From baseline up to March 2026, assessed annually

• Incidence of Hepatocellular Carcinoma (HCC)

  From baseline up to March 2026, assessed annually

• Liver-Related Mortality

  From baseline up to March 2026, assessed annually

• New-Onset Type 2 Diabetes Mellitus

  From baseline up to March 2026, assessed annually

Study Arms (1)

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.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age ≥60 years
• Presence of hepatic steatosis confirmed by baseline imaging (e.g., ultrasound, transient elastography) or liver biopsy

You may not qualify if:

• Missing data for key variables
• Pre-existing hepatocellular carcinoma or history of liver transplantation at baseline

Sponsors & Collaborators

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

Study Sites (1)

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

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: January 1, 2018
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)