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Type 2 Diabetes MellitusKNDPNCT01212198

Korea National Diabetes Program

An observational study of Type 2 Diabetes Mellitus and Diagnosis, run by Kyunghee University Medical Center at 12 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an observational study done by creating a cohort of Korean patients with diabetes and those at high risk of developing diabetes. By the creation of this cohort we aim to establish efficient preventive, diagnostic, and therapeutic measures based on the characteristics of Korean patients with diabetes, and by… Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Type 2 Diabetes Mellitus, Diagnosis, Treatment
How many people
6,000 participants
Where
12 sitesSouth Korea
Study dates
May 2005to Mar 2014
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 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Korean patients with type 2 diabetes, Koreans at high risk for diabetes, Korean patients with gestational diabetes

Who may be able to join

  • (Group 1:Diagnostic criteria for type 2 diabetes based on ADA 2004 guidelines)
  • random plasma glucose >200mg/dL + symptoms such as polyuria, polydipsia, unexplained weight loss
  • fasting plasma glucose >126 mg/dL or 75g oral glucose tolerance test (OGTT) 2h plasma glucose >200 mg/dL (Group 2: High risk for diabetes based on ADA 2004 guidelines)
  • IFG: fasting plasma glucose 100-125 mg/dL and 75g OGTT 2h plasma glucose <140 mg/dL
  • IGT: fasting plasma glucose <100 mg/dL and 75g OGTT 2h plasma glucose 140-199 mg/dL (Group 3: Gestational Diabetes based on ADA 2004 guidelines)
  • 50g OGTT 1h plasma glucose >140 mg/dl
  • 100g OGTT fasting plasma glucose >95 mg/dl, 1h plasma glucose >180 mg/dl, 2h plasma glucose >155 mg/dL, 3h plasma glucose >140 mg/dL

Who cannot join

  • -

Trial locations and contacts

12 sites in 1 country.

Young-Seol Kim, MD, PhD contact

+82-2-958-8339

kimys@khmc.or.kr

Suk Chon, MD, PhD contact

+82-2-958-8843

imdrjs@khu.ac.kr

12 sites in 1 country

South Korea12 sites, 12 recruiting

  • Yeungnam University Medical Center

    Daegu, 705-717

    Hyoung Woo Lee, MD, PhD, +82-53-620-3839, helee@med.yu.ac.kr

    Hyoung Woo Lee, MD, PhD

    Recruiting

  • Hanyang University Medical Center

    Guri-si, Kyunggi, 471-020

    Yongsoo Park, MD, PhD, +82-31-553-7369, parkys@hanyang.ac.kr

    Yongsoo Park, MD, PhD

    Recruiting

  • Gachon University Gil Hospital

    Incheon, Namdong

    Ie-Byung Park, MD, PhD, +82-32-460-3213, park712@gilhospital.com

    Ie-Byung Park, MD, PhD

    Recruiting

  • Inha University Hospital

    Incheon, 400-711

    Moon-Suk Nam, MD, PhD, +82-32-890-3495, namms@inha.ac.kr

    Moon-Suk Nam, MD, PhD

    Recruiting

  • Pusan National University Hospital

    Pusan, 602-739

    In-Ju Kim, MD, PhD, +82-51-240-7970, injkim@pusan.ac.kr

    In-Ju Kim, MD, PhD

    Recruiting

  • Cheil General Hospital

    Seoul, 100-380

    SungHoon Kim, MD, PhD, +82-2-2000-7271, hoonie.kim@cgh.co.kr

    SungHoon Kim, MD, PhD

    Recruiting

  • Kyunghee University Medical Center

    Seoul, 130-702

    Young-Seol Kim, MD, PhD, +82-2-958-8339, kimys@khmc.or.kr

    Suk Chon, MD, PhD, +82-2-958-8843, imdrjs@khu.ac.kr

    Recruiting

  • Kangdong Sacred Heart Hospital Hallym University

    Seoul, 134-701

    DooMan Kim, MD, PhD, +82-2-2224-2575, dm@hallym.or.kr

    DooMan Kim, MD, PhD

    Recruiting

  • Inje University Sanggye-Paik Hospital

    Seoul, 139-707

    Kyung Soo Ko, MD, PhD, +82-2-950-1114, kskomd@sanggyepaik.ac.kr

    Kyung Soo Ko, MD, PhD

    Recruiting

  • Korea University Guro Hospital

    Seoul, 152-730

    Sei Hyun Baik, MD, PhD, +82-2-818-6645, 103hyun@korea.ac.kr

    Sei Hyun Baik, MD, PhD

    Recruiting

  • Kyung Hee University East West Neo Medical Center

    Seoul

    Kyu-Jeung Ahn, MD, PhD, +82-2-440-7055, ahn_kyujeung@yahoo.ca

    Kyu-Jeung Ahn, MD, PhD

    Recruiting

  • Ajou University Medical Center

    Suwon, 443-721

    Kwan-Woo Lee, MD, PhD, +82-31-219-4526, LKW65@ajou.ac.kr

    Kwan-Woo Lee, MD, PhD

    Recruiting

Other trials in South Korea

About this study

Official title: Clinical Research Center For Type 2 Diabetes Mellitus - Observational Cohort Study of Type 2 Diabetes Mellitus

This is an observational study done by creating a cohort of Korean patients with diabetes and those at high risk of developing diabetes. By the creation of this cohort we aim to establish efficient preventive, diagnostic, and therapeutic measures based on the characteristics of Korean patients with diabetes, and by doing so, we hope to ultimately decrease our country's diabetes-related-mortality and increase the quality of life of patients with type 2 diabetes.

Read the detailed description

It is estimated that in 20 years the number of patients with diabetes will be over 6 million. Therefore the importance of diagnosis, treatment, and prevention of diabetes needs no further emphasis. At the moment, current studies demonstrate that mortality has increased twofold in the last 10 years due to lack of adequate control, and that medical expenses related to diabetes is increasing. Therefore, the necessity to find means for effective prevention and management of diabetes seems pressing.

However, unfortunately, in Korea, results of systematic clinical trials carried out in the Korean population are not available. All the currently available management guidelines have been formulated based on the results of clinical trials carried out in other populations, on patients with perhaps different characteristics compared to ours. There are quite a number of problems in applying these guidelines to our patients.

This study's purpose is to create a basis on which we could establish effective prevention, diagnosis, and therapeutic plan based on specific characteristics of Korean patients with type 2 diabetes.

Medical subject headings
Diabetes Mellitus, Type 2, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01212198
Study groupRoleWhat they receive
Korean type 2 diabetic patientsNot described
Koreans at high risk for diabetesNot described
Korean gestational diabetic patientsNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Specific characteristics of Korean type 2 diabetic patients

    The investigators will investigate the characteristics of Korean type 2 diabetic patient.

    First planning time frame is up to 10 years, but this time frame can be needed, if needed. (If we need the extension of study duration, new informed consent will be gotten from patients)

    Measured: up to 10 years

  2. Diabetes complications incidence and mortality in Korean type 2 diabetic patients

    The investigators will investigate the characteristics of Korean type 2 diabetic patient.

    First planning time frame is up to 10 years, but this time frame can be needed, if needed. (If we need the extension of study duration, new informed consent will be gotten from patients)

    Measured: up to 10 years

  3. Investigation of Korean type 2 diabetic patients' lifestyle

    The investigators will investigate the characteristics of Korean type 2 diabetic patient.

    First planning time frame is up to 10 years, but this time frame can be needed, if needed. (If we need the extension of study duration, new informed consent will be gotten from patients)

    Measured: up to 10 years

  4. Economic evaluation of Korean type 2 diabetic patients

    The investigators will investigate the characteristics of Korean type 2 diabetic patient.

    First planning time frame is up to 10 years, but this time frame can be needed, if needed. (If we need the extension of study duration, new informed consent will be gotten from patients)

    Measured: up to 10 years

  5. Incidence of diabetes in patients with high risk for diabetes and gestational diabetes in Koreans

    The investigators will investigate the characteristics of Korean type 2 diabetic patient.

    First planning time frame is up to 10 years, but this time frame can be needed, if needed. (If we need the extension of study duration, new informed consent will be gotten from patients)

    Measured: up to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Sep 2010 (estimated)
  2. Study startMay 2005
  3. Study completionMar 2014 (estimated)

Resources

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
6,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01212198
Sponsor's protocol ID
KNDP-KMC-0505
Acronym
KNDP
Status last verified
Sep 2010
First submitted
29 Sep 2010
Last updated
25 Oct 2010
Results posted
No
Data monitoring committee
Yes

Publications

  • Kim SH, Hong SB, Suh YJ, Choi YJ, Nam M, Lee HW, Park IeB, Chon S, Woo JT, Baik SH, Park Y, Kim DJ, Lee KW, Kim YS; KNDP Study Group. Association between nutrient intake and obesity in type 2 diabetic patients from the Korean National Diabetes Program: a cross-sectional study. J Korean Med Sci. 2012 Oct;27(10):1188-95. doi: 10.3346/jkms.2012.27.10.1188. Epub 2012 Oct 2.

    PubMed 23091316

  • Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.

    PubMed 22837306

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus and Diagnosis, run by Kyunghee University Medical Center at 12 sites 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 7 inclusion and 1 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 25 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites 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 Young-Seol Kim, MD, PhD (+82-2-958-8339, kimys@khmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Specific characteristics of Korean type 2 diabetic patients (time frame: up to 10 years). The study lists 5 primary outcomes in all. 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 NCT01212198, which also lists 2 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 25 Oct 2010; AzTrials last refreshed its copy on 28 Oct 2026.

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