Metabolic Subtypes of Non-Alcoholic Fatty Liver Disease

June 20, 2024 updated by: Yan Bi

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Division of Endocrinology, the Affiliated Drum Tower Hospital of Nanjing University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Ischemic heart disease
Time Frame: up to 5 years
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
Time Frame: up to 5 years
Documented Myocardial Infarction or Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting
up to 5 years
histological cirrhosis checklist
Time Frame: up to 5 years
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
Time Frame: up to 5 years
the diagnosis of hepatocellular carcinoma was based on well-established diagnostic imaging criteria and/or histology.
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Yan Bi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 5, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 30, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings