Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

NCT05560997 | Unknown

• 1 other identifier: NAFLDcluster
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Alcoholic Fatty Liver Disease; Machine Learning

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

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

longitudinal physical examination cohort

The diagnosis of NAFLD was based on imaging evaluation.

Diagnostic Test: 10-year ASCVD risk estimation

Interventions

10-year ASCVD risk estimation DIAGNOSTIC_TEST

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.

biopsy-proved NAFLD cohort; longitudinal physical examination cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• biopsy-proved NALD cohort:
• age 18 to 75 years
• receiving liver biopsy at the time of metabolic surgery
• relatively complete clinical information, including physical examination, biochemical and haematological assessments
• longitudinal cohort
• age 18 to 75 years
• receiving abdominal imaging examinations,
• relatively complete clinical information, including physical examination, biochemical and haematological assessments (4）follow-up time at least more than 12 months

You may not qualify if:

• (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

Sponsors & Collaborators

• Yan Bi: lead

Study Sites (1)

Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: September 30, 2022
• Study Start: January 5, 2016
• Primary Completion: October 30, 2024
• Study Completion: June 1, 2025
• Last Updated: June 21, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)