- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212198
Korea National Diabetes Program (KNDP)
Clinical Research Center For Type 2 Diabetes Mellitus - Observational Cohort Study of Type 2 Diabetes Mellitus
Study Overview
Status
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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Young-Seol Kim, MD, PhD
- Phone Number: +82-2-958-8339
- Email: kimys@khmc.or.kr
Study Contact Backup
- Name: Suk Chon, MD, PhD
- Phone Number: +82-2-958-8843
- Email: imdrjs@khu.ac.kr
Study Locations
-
-
-
Daegu, Korea, Republic of, 705-717
- Recruiting
- Yeungnam University Medical Center
-
Contact:
- Hyoung Woo Lee, MD, PhD
- Phone Number: +82-53-620-3839
- Email: helee@med.yu.ac.kr
-
Principal Investigator:
- Hyoung Woo Lee, MD, PhD
-
In Cheon, Korea, Republic of, 400-711
- Recruiting
- Inha University Hospital
-
Contact:
- Moon-Suk Nam, MD, PhD
- Phone Number: +82-32-890-3495
- Email: namms@inha.ac.kr
-
Principal Investigator:
- Moon-Suk Nam, MD, PhD
-
Pusan, Korea, Republic of, 602-739
- Recruiting
- Pusan National University Hospital
-
Contact:
- In-Ju Kim, MD, PhD
- Phone Number: +82-51-240-7970
- Email: injkim@pusan.ac.kr
-
Principal Investigator:
- In-Ju Kim, MD, PhD
-
Seoul, Korea, Republic of, 130-702
- Recruiting
- Kyunghee University Medical Center
-
Sub-Investigator:
- Suk Chon, MD, PhD
-
Contact:
- Young-Seol Kim, MD, PhD
- Phone Number: +82-2-958-8339
- Email: kimys@khmc.or.kr
-
Contact:
- Suk Chon, MD, PhD
- Phone Number: +82-2-958-8843
- Email: imdrjs@khu.ac.kr
-
Sub-Investigator:
- Jeong-taek Woo, MD, PhD
-
Principal Investigator:
- Young-Seol Kim, MD, PhD
-
Sub-Investigator:
- Seungjoon Oh, MD, PhD
-
Sub-Investigator:
- Sung-Woon Kim, MD, PhD
-
Sub-Investigator:
- Jin-Woo Kim, MD, PhD
-
Sub-Investigator:
- Yun Jung Lee, MD
-
Sub-Investigator:
- Moon Chan Choi, MD
-
Seoul, Korea, Republic of, 100-380
- Recruiting
- Cheil General Hospital
-
Contact:
- SungHoon Kim, MD, PhD
- Phone Number: +82-2-2000-7271
- Email: hoonie.kim@cgh.co.kr
-
Principal Investigator:
- SungHoon Kim, MD, PhD
-
Seoul, Korea, Republic of, 134-701
- Recruiting
- Kangdong Sacred Heart Hospital Hallym University
-
Contact:
- DooMan Kim, MD, PhD
- Phone Number: +82-2-2224-2575
- Email: dm@hallym.or.kr
-
Principal Investigator:
- DooMan Kim, MD, PhD
-
Seoul, Korea, Republic of, 139-707
- Recruiting
- Inje University Sanggye-Paik Hospital
-
Contact:
- Kyung Soo Ko, MD, PhD
- Phone Number: +82-2-950-1114
- Email: kskomd@sanggyepaik.ac.kr
-
Principal Investigator:
- Kyung Soo Ko, MD, PhD
-
Seoul, Korea, Republic of, 152-730
- Recruiting
- Korea University Guro Hospital
-
Contact:
- Sei Hyun Baik, MD, PhD
- Phone Number: +82-2-818-6645
- Email: 103hyun@korea.ac.kr
-
Principal Investigator:
- Sei Hyun Baik, MD, PhD
-
Seoul, Korea, Republic of
- Recruiting
- Kyung Hee University East West Neo Medical Center
-
Contact:
- Kyu-Jeung Ahn, MD, PhD
- Phone Number: +82-2-440-7055
- Email: ahn_kyujeung@yahoo.ca
-
Principal Investigator:
- Kyu-Jeung Ahn, MD, PhD
-
Suwon, Korea, Republic of, 443-721
- Recruiting
- Ajou University Medical Center
-
Contact:
- Kwan-Woo Lee, MD, PhD
- Phone Number: +82-31-219-4526
- Email: LKW65@ajou.ac.kr
-
Principal Investigator:
- Kwan-Woo Lee, MD, PhD
-
-
Kyunggi
-
Kuri, Kyunggi, Korea, Republic of, 471-020
- Recruiting
- Hanyang University Medical Center
-
Contact:
- Yongsoo Park, MD, PhD
- Phone Number: +82-31-553-7369
- Email: parkys@hanyang.ac.kr
-
Principal Investigator:
- Yongsoo Park, MD, PhD
-
-
Namdong
-
In Cheon, Namdong, Korea, Republic of
- Recruiting
- Gachon University Gil Hospital
-
Contact:
- Ie-Byung Park, MD, PhD
- Phone Number: +82-32-460-3213
- Email: park712@gilhospital.com
-
Principal Investigator:
- Ie-Byung Park, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Korean type 2 diabetic patients
|
Koreans at high risk for diabetes
|
Korean gestational diabetic patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific characteristics of Korean type 2 diabetic patients
Time Frame: up to 10 years
|
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
Time Frame: up to 10 years
|
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
Time Frame: up to 10 years
|
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
Time Frame: up to 10 years
|
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
Time Frame: up to 10 years
|
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
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Young-Seol Kim, MD, PhD, Kyunghee University Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KNDP-KMC-0505
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes Mellitus
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
AstraZenecaNot yet recruiting
-
Daewoong Pharmaceutical Co. LTD.Not yet recruitingT2DM (Type 2 Diabetes Mellitus)
-
Zhongda HospitalRecruitingType 2 Diabetes Mellitus (T2DM)China