Metabolic DiseasesNCT00707668
Chung-ju Metabolic Disease Cohort (CMC) Study
An observational study of Metabolic Diseases, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Diseases
- How many people
- 10,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2007to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults over 30 years of age living in Chung-ju city
Who may be able to join
- Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study)
Who cannot join
- age under 30
- subjects with known diabetes
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Chung-ju health care center
Chungju, Chungchungbook-do
Seung D Shin, RN, 82-43-850-7349, ssdeug@naver.com
Ho-Young Son, M.D.,Ph.D.
About this study
This is an observational study on the prevalence and incidence of diabetes and osteoporosis in a rural area of Korea.
Read the 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.
- Conditions
- Metabolic Diseases
- Keywords
- Diabetes, metabolic syndrome, dyslipidemia, osteoporosis
- Medical subject headings
- Metabolic Diseases, Diabetes Mellitus, Metabolic Syndrome, Dyslipidemias, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Chung-ju cohort populations aged over 30 year-old |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of diabetes
Measured: 4 years
Secondary outcomes (2)
The prevalence of metabolic syndrome, dyslipidemia and osteoporosis
Measured: 4 years
Insulin sensitivity and resistance of Korean subjects
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2008 (estimated)
- Study startMay 2007
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kun-Ho Yoon, The Catholic University of Korea
- Investigators
- Kun-Ho Yoon, M.D., Ph.D., Study director, Kangnam St.Mary's hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00707668
- Sponsor's protocol ID
- KCMC07OT076
- Status last verified
- Jul 2014
- First submitted
- 27 Jun 2008
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16491829
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chung-ju Metabolic Disease Cohort (CMC) Study
- ClinicalTrials.gov ID
- NCT00707668
- Acronym / sponsor ID
- KCMC07OT076
- Conditions
- Metabolic Diseases
- Keywords
- Diabetes, metabolic syndrome, dyslipidemia, osteoporosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 1 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Chung-ju cohort populations aged over 30 year-old |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults over 30 years of age living in Chung-ju city
Key inclusion criteria (1 listed)
- Adults over 30 years of age living in Chung-ju city (who participated in 2003-2006 cohort study)
Key exclusion criteria (2 listed)
- age under 30
- subjects with known diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The incidence of diabetes
Time frame: 4 years
2 secondary outcomes
The prevalence of metabolic syndrome, dyslipidemia and osteoporosis
Time frame: 4 years
Insulin sensitivity and resistance of Korean subjects
Time frame: 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
- Background: PubMed 16491829Kwon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kun-Ho Yoon, M.D., Ph.D. study director
Kangnam St.Mary's hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Diseases, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kun-Ho Yoon, M.D., Ph.D. (82-2-590-1402, yoonk@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of diabetes (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00707668, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.