NCT02640859

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,003

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 29, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2019

Completed
Last Updated

March 15, 2019

Status Verified

March 1, 2019

Enrollment Period

3.2 years

First QC Date

December 19, 2015

Last Update Submit

March 14, 2019

Conditions

Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiovascular disease

    5 years

Secondary Outcomes (5)

  • Incidence of diabetes mellitus

    5 years

  • Incidence of fatty liver

    5 years

  • Incidence of metabolic syndrome

    5 years

  • Incidence of osteoporosis

    5 years

  • Incidence of sarcopenia

    5 years

Study Arms (1)

Normal cohort

Normal cohort for biobank

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy Korean Adults

You may qualify if:

  • 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

You may not qualify if:

  • Malignancy
  • Chronic wasting disease
  • Long-term steroid use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

For measuring biomarkers

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Soo Lim, MD, PhD

    SNUBH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 19, 2015

First Posted

December 29, 2015

Study Start

September 1, 2015

Primary Completion

November 30, 2018

Study Completion

February 28, 2019

Last Updated

March 15, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)