Chung-ju Metabolic Disease Cohort (CMC) Study | NCT00707668

Studies
Chung-ju Metabolic Disease Cohort (CMC) Study

NCT00707668

Sponsor

The Catholic University of Korea

Status

Unknown status

Last Update Posted

Jul 28, 2014Estimated

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Metabolic Diseases

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

Jul 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2007

Primary Completion Date

Feb 2016Estimated

Completion Date

Feb 2016Estimated

First Submitted Date

Jun 27, 2008

First Submission Date that Met QC Criteria

Jun 27, 2008

First Posted Date

Jul 1, 2008Estimated

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

Jul 25, 2014

Last Update Posted Date

Jul 28, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kun-Ho Yoon, Professor, The Catholic University of KoreaPrincipal Investigator

Lead Sponsor

The Catholic University of KoreaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea.

Detailed Description

Diabetes, metabolic syndrome and dyslipidemia are common and rapidly increasing in Asia. Our group constructed a cohort in Chung-ju city, a rural area in Korea, to observe the prevalence of metabolic diseases and its risk factors since 2003. About 12,000 subjects participated in this cohort study till 2006. Now, we are planning to follow-up these subjects and provide health examinations from May, 2007 to Feb, 2011. The prevalence and incidence of metabolic diseases including diabetes, hypertension, metabolic syndrome, dislipidemia and osteoporosis will be observed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Label	Type	Description	Intervention Names
Control		Chung-ju cohort populations aged over 30 year-old

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The incidence of diabetes		4 years

Secondary Outcomes

Measure	Description	Time Frame
The prevalence of metabolic syndrome, dyslipidemia and osteoporosis		4 years
Insulin sensitivity and resistance of Korean subjects		4 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study)

Exclusion Criteria:

age under 30
subjects with known diabetes

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults over 30 years of age living in Chung-ju city

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kun-Ho Yoon, M.D., Ph.D.	Contact	82-2-590-1402		yoonk@catholic.ac.kr
Seung-Hwan Lee, M.D.	Contact	82-2-590-1422		hwanx2@catholic.ac.kr

Overall Officials

Name	Affiliation	Role
Kun-Ho Yoon, M.D., Ph.D.	Kangnam St.Mary's hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chung-ju health care center	Recruiting	Chungju	Chungchungbook-do		South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16491829	Background	Kwon HS, Park YM, Lee HJ, Lee JH, Choi YH, Ko SH, Lee JM, Kim SR, Kang SY, Lee WC, Ahn MS, Noh JH, Kang JM, Kim DS, Yoon KH, Cha BY, Lee KW, Kang SK, Son HY. Prevalence and clinical characteristics of the metabolic syndrome in middle-aged Korean adults. Korean J Intern Med. 2005 Dec;20(4):310-6. doi: 10.3904/kjim.2005.20.4.310.

ID	Term
D008659	Metabolic Diseases
D003920	Diabetes Mellitus
D024821	Metabolic Syndrome
D050171	Dyslipidemias
D010024	Osteoporosis

ID	Term
D009750	Nutritional and Metabolic Diseases
D044882	Glucose Metabolism Disorders
D004700	Endocrine System Diseases
D007333	Insulin Resistance