Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

Yan Bi

Status: Enrolling

Conditions: Machine Learning; Non-Alcoholic Fatty Liver Disease

Treatments: Diagnostic Test: 10-year ASCVD risk estimation

Study type: Observational

Funder types: Other

Identifiers

NCT05560997

NAFLDcluster

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,000 participants in 2 patient groups

biopsy-proved NAFLD cohort

Description:

NAFLD is defined as the presence of at least 5% steatosis based on histological examination.

Treatment:

Diagnostic Test: 10-year ASCVD risk estimation

longitudinal physical examination cohort

Description:

The diagnosis of NAFLD was based on imaging evaluation.

Treatment:

Diagnostic Test: 10-year ASCVD risk estimation