Korea National Diabetes Program

NCT ID: NCT01212198

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

6000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-05-31

Study Completion Date

2014-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus Diagnosis Treatment Prevention Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Korean type 2 diabetic patients

No interventions assigned to this group

Koreans at high risk for diabetes

No interventions assigned to this group

Korean gestational diabetic patients

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

(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

Exclusion Criteria

\-
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Korea University Guro Hospital

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Inha University Hospital

OTHER

Sponsor Role collaborator

Ajou University

OTHER

Sponsor Role collaborator

East West Neo Medical Center

OTHER

Sponsor Role collaborator

Pusan National University Hospital

OTHER

Sponsor Role collaborator

Gachon University Gil Medical Center

OTHER

Sponsor Role collaborator

Cheil General Hospital and Women's Healthcare Center

OTHER

Sponsor Role collaborator

Yeungnam University Hospital

OTHER

Sponsor Role collaborator

Inje University

OTHER

Sponsor Role collaborator

Kangdong Sacred Heart Hospital

OTHER

Sponsor Role collaborator

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Kyunghee University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Kyunghee University Medical Center

Principal Investigators

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Young-Seol Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Kyunghee University Medical Center

Locations

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Hanyang University Medical Center

Guri-si, Kyunggi, South Korea

Site Status RECRUITING

Gachon University Gil Hospital

Incheon, Namdong, South Korea

Site Status RECRUITING

Yeungnam University Medical Center

Daegu, , South Korea

Site Status RECRUITING

Inha University Hospital

Incheon, , South Korea

Site Status RECRUITING

Pusan National University Hospital

Pusan, , South Korea

Site Status RECRUITING

Cheil General Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyunghee University Medical Center

Seoul, , South Korea

Site Status RECRUITING

Kangdong Sacred Heart Hospital Hallym University

Seoul, , South Korea

Site Status RECRUITING

Inje University Sanggye-Paik Hospital

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

Kyung Hee University East West Neo Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ajou University Medical Center

Suwon, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Young-Seol Kim, MD, PhD

Role: CONTACT

+82-2-958-8339

Suk Chon, MD, PhD

Role: CONTACT

+82-2-958-8843

Facility Contacts

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Yongsoo Park, MD, PhD

Role: primary

+82-31-553-7369

Ie-Byung Park, MD, PhD

Role: primary

+82-32-460-3213

Hyoung Woo Lee, MD, PhD

Role: primary

+82-53-620-3839

Moon-Suk Nam, MD, PhD

Role: primary

+82-32-890-3495

In-Ju Kim, MD, PhD

Role: primary

+82-51-240-7970

SungHoon Kim, MD, PhD

Role: primary

+82-2-2000-7271

Young-Seol Kim, MD, PhD

Role: primary

+82-2-958-8339

Suk Chon, MD, PhD

Role: backup

+82-2-958-8843

DooMan Kim, MD, PhD

Role: primary

+82-2-2224-2575

Kyung Soo Ko, MD, PhD

Role: primary

+82-2-950-1114

Sei Hyun Baik, MD, PhD

Role: primary

+82-2-818-6645

Kyu-Jeung Ahn, MD, PhD

Role: primary

+82-2-440-7055

Kwan-Woo Lee, MD, PhD

Role: primary

+82-31-219-4526

References

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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.

Reference Type DERIVED
PMID: 23091316 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22837306 (View on PubMed)

Other Identifiers

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KNDP-KMC-0505

Identifier Type: -

Identifier Source: org_study_id