NCT03534908

Brief Summary

Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world. NAFLD is associated with a lot of comorbidity, such as diabetes, metabolic syndrome, coronary heart disease and chronic kidney diseases. However, the correlation between the NAFLD and cardiovascular disease (CVD) events remains controversial. This study is an observational study based on a big retrospective cohort in china to explore the prevalence of NAFLD in China, the risk factors associated with NAFLD, as well as whether patients with NAFLD are more prone to experience CVDs and CVD events.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 11, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 23, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 8, 2019

Status Verified

October 1, 2019

Enrollment Period

3 years

First QC Date

May 11, 2018

Last Update Submit

October 3, 2019

Conditions

NAFLDCardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

  • the prevalence of NAFLD in China

    June，2020

Secondary Outcomes (2)

  • the risk factors associated with NAFLD

    August，2020

  • to indicate the prevalence of CVDs and CVD events in people with and without NAFLD

    October，2020

Study Arms (2)

NAFLD group

those with NAFLD

Control group

those without NAFLD

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

People who have taken medical examination and health checkup in the health management centers of hospitals in China.

You may qualify if:

  • males or females aged 18-75

You may not qualify if:

  • malignancy except primary liver cancer
  • pregnancy or breastfeeding
  • liver diseases of other etiology including hepatitis C virus infection ,autoimmune hepatitis,Wilson's disease,hemachromatosis,drug-induced hepatitis,parenteral nutrition
  • excessive alcohol consumption
  • cases missing crucial data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wuhan University

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseCardiovascular Diseases

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Hongliang Li, MD,PhD

    Wuhan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

May 11, 2018

First Posted

May 23, 2018

Study Start

September 25, 2017

Primary Completion

September 30, 2020

Study Completion

June 30, 2021

Last Updated

October 8, 2019

Record last verified: 2019-10

Locations

CN(1)