Nonalcoholic Fatty Liver Disease and Cardiovascular Disea... | NCT03534908

Studies
Nonalcoholic Fatty Liver Disease and Cardiovascular Disease: the Correlation Analysis and Risk Prediction Model Study

NCT03534908

Sponsor

Wuhan University

Status

Unknown status

Last Update Posted

Oct 8, 2019Actual

Enrollment

5,000,000Estimated

Phase

Not provided

Conditions

NAFLD
Cardiovascular Diseases

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 25, 2017Actual

Primary Completion Date

Sep 30, 2020Estimated

Completion Date

Jun 30, 2021Estimated

First Submitted Date

May 11, 2018

First Submission Date that Met QC Criteria

May 11, 2018

First Posted Date

May 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2019

Last Update Posted Date

Oct 8, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NAFLD group		those with NAFLD
Control group		those without NAFLD

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the prevalence of NAFLD in China		June，2020

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

males or females aged 18-75

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hongliang Li, MD,PhD	Wuhan University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wuhan University		Wuhan	Hubei	430000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065626	Non-alcoholic Fatty Liver Disease
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D005234	Fatty Liver
D008107	Liver Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided