NCT01212198

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2005

Longer than P75 for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
5.4 years until next milestone

First Submitted

Initial submission to the registry

September 29, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 30, 2010

Completed
3.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

October 25, 2010

Status Verified

September 1, 2010

First QC Date

September 29, 2010

Last Update Submit

October 22, 2010

Conditions

Type 2 Diabetes MellitusDiagnosisTreatmentPreventionComplications

Outcome Measures

Primary Outcomes (5)

  • 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)

    up to 10 years

  • 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)

    up to 10 years

  • 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)

    up to 10 years

  • 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)

    up to 10 years

  • 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)

    up to 10 years

Study Arms (3)

Korean type 2 diabetic patients

Koreans at high risk for diabetes

Korean gestational diabetic patients

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • (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)
  • g OGTT 1h plasma glucose \>140 mg/dl
  • g 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Hanyang University Medical Center

Guri-si, Kyunggi, 471-020, South Korea

RECRUITING

Gachon University Gil Hospital

Incheon, Namdong, South Korea

RECRUITING

Yeungnam University Medical Center

Daegu, 705-717, South Korea

RECRUITING

Inha University Hospital

Incheon, 400-711, South Korea

RECRUITING

Pusan National University Hospital

Pusan, 602-739, South Korea

RECRUITING

Cheil General Hospital

Seoul, 100-380, South Korea

RECRUITING

Kyunghee University Medical Center

Seoul, 130-702, South Korea

RECRUITING

Kangdong Sacred Heart Hospital Hallym University

Seoul, 134-701, South Korea

RECRUITING

Inje University Sanggye-Paik Hospital

Seoul, 139-707, South Korea

RECRUITING

Korea University Guro Hospital

Seoul, 152-730, South Korea

RECRUITING

Kyung Hee University East West Neo Medical Center

Seoul, South Korea

RECRUITING

Ajou University Medical Center

Suwon, 443-721, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 23091316DERIVED

  • 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.

    PMID: 22837306DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, and urine

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Disease

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Young-Seol Kim, MD, PhD

    Kyunghee University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Seol Kim, MD, PhD

CONTACT

+82-2-958-8339kimys@khmc.or.kr

Suk Chon, MD, PhD

CONTACT

+82-2-958-8843imdrjs@khu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 29, 2010

First Posted

September 30, 2010

Study Start

May 1, 2005

Study Completion

March 1, 2014

Last Updated

October 25, 2010

Record last verified: 2010-09

Locations

KR(12)