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Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05560997
Enrollment
1000
Registered
2022-09-30
Start date
2016-01-05
Completion date
2025-06-01
Last updated
2024-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Machine Learning, Non-Alcoholic Fatty Liver Disease

Brief summary

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

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.

Interventions

DIAGNOSTIC_TEST10-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.

Sponsors

Yan Bi
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
histological cirrhosis checklistup to 5 yearscirrhosis was defined as widespread disruption of normal liver structure by the formation of pseudolobules or Scheuer stage 4 fibrosis in pathological findings.
hepatocellular carcinomaup to 5 yearsthe diagnosis of hepatocellular carcinoma was based on well-established diagnostic imaging criteria and/or histology.
Ischemic heart diseaseup to 5 yearsObjective 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
Documented heart disease checklistup to 5 yearsDocumented Myocardial Infarction or Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026