Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05560997
• Other study ID #: NAFLDcluster
• Status: Recruiting
• Start date: January 5, 2016
• Est. completion date: June 1, 2025

Study information

• Verified date: September 2023
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Machine Learning
• Non-Alcoholic Fatty Liver Disease

Intervention

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.

Locations

Country	Name	City	State
China	Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Yan Bi

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Documented heart disease checklist	Documented Myocardial Infarction or Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting	up to 5 years
Primary	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
Primary	hepatocellular carcinoma	the diagnosis of hepatocellular carcinoma was based on well-established diagnostic imaging criteria and/or histology.	up to 5 years