Apparently Healthy Elderly PeopleNCT01977391
Association Between Mortality and Diabetes in Elderly Koreans: the South-West Seoul (SWS) Study
An observational study of Apparently Healthy Elderly People and (Between 60-92 Years of Age), run by Korea University at 1 site in South Korea.
Trial summary
Diabetes mellitus is known to increase the risk of premature death in the general population. In this study, the investigators examine the impact of body mass index (BMI) levels, waist circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in elderly Koreans. Read more about this study
- Who is it for?
- Ages 60 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Apparently Healthy Elderly People, (Between 60-92 Years of Age)
- How many people
- 2,263 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 1999to Dec 2011
- How long will I take part?
- 10 Years
- 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 60 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study subjects in South-West Seoul (SWS) study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.
Who may be able to join
- Apparently healthy individuals
- Over the age of 60 years
Who cannot join
- Those with a mismatched identification number
- Missing data regarding BMI, waist circumference, and presence of diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Diabetes mellitus is known to increase the risk of premature death in the general population. In this study, the investigators examine the impact of body mass index (BMI) levels, waist circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in elderly Koreans.
Read the detailed description
The investigators analyze follow-up data from the South-West Seoul (SWS) Study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.
Briefly, the study population was selected from four urban districts (Guro, Yangcheon, Gwanak and Gangseo) located in the south-west area of Seoul. A total of 1737 apparently healthy individuals (between 60 and 92 years of age) eventually participated in this survey starting in 1999. A follow-up examination was performed in 2002, and an additional 873 subjects who had not participated in the first examination were newly recruited.
After a median follow-up of 10 years, each subject's vital status or cause of death as of 31 December 2011 was determined after linking these cohort data with death certificate data from the Korean National Statistical Office. Terminology and codes from the International Classification of Disease, Tenth Revision (ICD-10), were used to classify the underlying cause of death due to cardiovascular disease (ICD-10 codes I00-I79), cancer (ICD-10 codes C00-C97) and others.
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause and cardiovascular mortality in elderly Korean men and women according to BMI, waist circumference, and presence of diabetes
Measured: A median follow-up of 10 years
Secondary outcomes (1)
Survival probability among study populations
Measured: A median follow-up of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2013 (estimated)
- Study startAug 1999
- Primary completionDec 2002
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Apparently Healthy Elderly PeopleStudies 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
- 2,263 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Korea University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. M. Choi, Korea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01977391
- Sponsor's protocol ID
- SWS(mortality, DM)
- Status last verified
- Nov 2013
- First submitted
- 30 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Choi KM, Lee J, Kim DR, Kim SK, Shin DH, Kim NH, Park IB, Choi DS, Baik SH. Comparison of ADA and WHO criteria for the diagnosis of diabetes in elderly Koreans. Diabet Med. 2002 Oct;19(10):853-7. doi: 10.1046/j.1464-5491.2002.00783.x.
PubMed 12358874Choi KM, Lee J, Kim KB, Kim DR, Kim SK, Shin DH, Kim NH, Park IB, Choi DS, Baik SH; South-west Seoul Study. Factor analysis of the metabolic syndrome among elderly Koreans--the South-west Seoul Study. Diabet Med. 2003 Feb;20(2):99-104. doi: 10.1046/j.1464-5491.2003.00890.x.
PubMed 12581260Kim NH, Cho HJ, Kim YJ, Cho MJ, Choi HY, Eun CR, Kim JH, Yang SJ, Yoo HJ, Kim HY, Seo JA, Kim SG, Baik SH, Choi DS, Choi KM. Combined effect of high-normal blood pressure and low HDL cholesterol on mortality in an elderly Korean population: the South-West Seoul (SWS) study. Am J Hypertens. 2011 Aug;24(8):918-23. doi: 10.1038/ajh.2011.78. Epub 2011 Apr 28.
PubMed 21525969
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Mortality and Diabetes in Elderly Koreans: the South-West Seoul (SWS) Study
- ClinicalTrials.gov ID
- NCT01977391
- Acronym / sponsor ID
- SWS(mortality, DM)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,263 participants (actual)
- Lead sponsor
- Korea UniversityUniversity, hospital or other
- Study start
- Aug 1999
- Primary completion
- Dec 2002 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 6 Nov 2013 (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.
Diabetes mellitus is known to increase the risk of premature death in the general population. In this study, the investigators examine the impact of body mass index (BMI) levels, waist circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in elderly Koreans.
Detailed description
The investigators analyze follow-up data from the South-West Seoul (SWS) Study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.
Briefly, the study population was selected from four urban districts (Guro, Yangcheon, Gwanak and Gangseo) located in the south-west area of Seoul. A total of 1737 apparently healthy individuals (between 60 and 92 years of age) eventually participated in this survey starting in 1999. A follow-up examination was performed in 2002, and an additional 873 subjects who had not participated in the first examination were newly recruited.
After a median follow-up of 10 years, each subject's vital status or cause of death as of 31 December 2011 was determined after linking these cohort data with death certificate data from the Korean National Statistical Office. Terminology and codes from the International Classification of Disease, Tenth Revision (ICD-10), were used to classify the underlying cause of death due to cardiovascular disease (ICD-10 codes I00-I79), cancer (ICD-10 codes C00-C97) and others.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 60 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study subjects in South-West Seoul (SWS) study, a prospective observational cohort study of an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.
Key inclusion criteria (2 listed)
- Apparently healthy individuals
- Over the age of 60 years
Key exclusion criteria (2 listed)
- Those with a mismatched identification number
- Missing data regarding BMI, waist circumference, and presence of 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
All-cause and cardiovascular mortality in elderly Korean men and women according to BMI, waist circumference, and presence of diabetes
Time frame: A median follow-up of 10 years
1 secondary outcome
Survival probability among study populations
Time frame: A median follow-up of 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
- Background: PubMed 12358874Choi KM, Lee J, Kim DR, Kim SK, Shin DH, Kim NH, Park IB, Choi DS, Baik SH. Comparison of ADA and WHO criteria for the diagnosis of diabetes in elderly Koreans. Diabet Med. 2002 Oct;19(10):853-7. doi: 10.1046/j.1464-5491.2002.00783.x.
- Background: PubMed 12581260Choi KM, Lee J, Kim KB, Kim DR, Kim SK, Shin DH, Kim NH, Park IB, Choi DS, Baik SH; South-west Seoul Study. Factor analysis of the metabolic syndrome among elderly Koreans--the South-west Seoul Study. Diabet Med. 2003 Feb;20(2):99-104. doi: 10.1046/j.1464-5491.2003.00890.x.
- Background: PubMed 21525969Kim NH, Cho HJ, Kim YJ, Cho MJ, Choi HY, Eun CR, Kim JH, Yang SJ, Yoo HJ, Kim HY, Seo JA, Kim SG, Baik SH, Choi DS, Choi KM. Combined effect of high-normal blood pressure and low HDL cholesterol on mortality in an elderly Korean population: the South-West Seoul (SWS) study. Am J Hypertens. 2011 Aug;24(8):918-23. doi: 10.1038/ajh.2011.78. Epub 2011 Apr 28.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Apparently Healthy Elderly People and (Between 60-92 Years of Age), run by Korea University 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 2 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: finished, as of the sponsor's last update on 7 Nov 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause and cardiovascular mortality in elderly Korean men and women according to BMI, waist circumference, and presence of diabetes (time frame: A median follow-up of 10 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 NCT01977391, which also lists 3 linked publications.
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 7 Nov 2013.