Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

Machine Learning to Identify Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

The purpose of this study was to use machine learning to explore a more precise classification of NAFLD subgroups towards informing individualized therapy.

Study Overview

• Status: Recruiting
• Conditions: Machine Learning; Non-Alcoholic Fatty Liver Disease
• Intervention / Treatment: Diagnostic test: 10-year ASCVD risk estimation

Detailed Description

Clinical characteristics of NAFLD are heterogenous, but current classification for diagnosis is simply based on pathological examination. The conventional pathological classification is insufficient to reflect the complexity and heterogeneity of NAFLD and can not predict the prognosis. Towards precision treatment, a more refined metabolic classification of NAFLD phenotypes is highly demanded for a personalized diagnosis, aiming to identify patients at elevated risk of cardiovascular disease or cirrhosis. This kind of refined classification can provide a more precise diagnosis and enable more individualized preventive interventions and early treatments. In a cross-sectional cohort, unsupervised machine learning was used to cluster patients with biopsy-proved NAFLD from Drum Tower Hospital Affiliated to Nanjing University Medical School based on clinical variables. Verification of the clustering was performed in a longitudinal cohort.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Recruiting
      • Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
      • Contact: Yan Bi, MD,PhD; Phone Number: 86-25-83-105302; Email: biyan@nju.edu.cn
      • Contact: Dalong Zhu, MD,PhD; Phone Number: 86-25-83-105302; Email: zhudldr@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

The study enrolled subjects who underwent liver biopsy or physical examination in Drum Tower Hospital affiliated to Nanjing University Medical School.

Description

Inclusion Criteria:

• biopsy-proved NALD cohort:

  1. age 18 to 75 years
  2. receiving liver biopsy at the time of metabolic surgery
  3. relatively complete clinical information, including physical examination, biochemical and haematological assessments

• longitudinal cohort

  1. age 18 to 75 years
  2. receiving abdominal imaging examinations,
  3. relatively complete clinical information, including physical examination, biochemical and haematological assessments (4）follow-up time at least more than 12 months

Exclusion Criteria:

• (1)consumed excessive alcohol (≥140 g/week for males or ≥ 70 g/week for females) •
• (2) with history of other liver diseases including chronic hepatitis, biliary obstructive diseases or autoimmune hepatitis

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
biopsy-proved NAFLD cohort; NAFLD is defined as the presence of at least 5% steatosis based on histological examination.	Diagnostic test: 10-year ASCVD risk estimation; High CVD risk was defined as a history of CVD or a 10-year ASCVD risk ≥10%. The 10-year ASCVD risk estimation was carried out according to 2016 Chinese guidelines for the management of dyslipidemia in adults.
longitudinal physical examination cohort; The diagnosis of NAFLD was based on imaging evaluation.	Diagnostic test: 10-year ASCVD risk estimation; High CVD risk was defined as a history of CVD or a 10-year ASCVD risk ≥10%. The 10-year ASCVD risk estimation was carried out according to 2016 Chinese guidelines for the management of dyslipidemia in adults.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ischemic heart disease	Objective Findings of Coronary Stenosis (≥ 50%) in at least 2 coronary artery territories (ie, left anterior descending, ramus intermedius, left circumflex, right coronary artery) involving the vain vessel, a major branch, or a bypass graft	up to 5 years
Documented heart disease checklist	Documented Myocardial Infarction or Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting	up to 5 years
histological cirrhosis checklist	cirrhosis was defined as widespread disruption of normal liver structure by the formation of pseudolobules or Scheuer stage 4 fibrosis in pathological findings.	up to 5 years
hepatocellular carcinoma	the diagnosis of hepatocellular carcinoma was based on well-established diagnostic imaging criteria and/or histology.	up to 5 years

Collaborators and Investigators

• Sponsor: Yan Bi

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2016
• Primary Completion (Estimated): October 30, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: September 26, 2022
• First Submitted That Met QC Criteria: September 29, 2022
• First Posted (Actual): September 30, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 20, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: NAFLDcluster

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