Investigation of Metabolic Risk in Korean Adults | NCT02640859

Studies
Investigation of Metabolic Risk in Korean Adults

NCT02640859

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Mar 15, 2019Actual

Enrollment

1,003Actual

Phase

Not provided

Conditions

Cardiovascular Disease

Interventions

Not provided

Countries

South Korea

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

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015Actual

Primary Completion Date

Nov 30, 2018Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Dec 19, 2015

First Submission Date that Met QC Criteria

Dec 22, 2015

First Posted Date

Dec 29, 2015Estimated

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

Mar 14, 2019

Last Update Posted Date

Mar 15, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

A cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Detailed Description

This is a prospective cohort study with Korean adults to investigate biomarkers in prediction of cardiometabolic and other diseases

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,003Actual

Label	Type	Description	Intervention Names
Normal cohort		Normal cohort for biobank

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of cardiovascular disease		5 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of diabetes mellitus		5 years
Incidence of fatty liver		5 years
Incidence of metabolic syndrome

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults without chronic diseases
Diabetic patients who are well controlled with oral antidiabetic agents
Hypertensive patients who are well controlled with oral antihypertensive agents
Dyslipidemic patients who are well controlled with oral lipid-lowering agents

Exclusion Criteria:

Malignancy
Chronic wasting disease
Long-term steroid use

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Healthy Korean Adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soo Lim, MD, PhD	SNUBH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si	Gyeonggi-do	463-707	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided