Korea National Diabetes Program (KNDP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Kyunghee University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Korea University Guro Hospital
Hanyang University
Inha University Hospital
Ajou University
East West Neo Medical Center
Pusan National University Hospital
Gachon University Gil Medical Center
Cheil General Hospital and Women’s Healthcare Center
Yeungnam University
Inje University
Kangdong Sacred Heart Hospital
Ministry of Health & Welfare, Korea
Information provided by:
Kyunghee University Medical Center
ClinicalTrials.gov Identifier:
NCT01212198
First received: September 29, 2010
Last updated: October 22, 2010
Last verified: September 2010
  Purpose

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.


Condition
Type 2 Diabetes Mellitus
Diagnosis
Treatment
Prevention
Complications

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Research Center For Type 2 Diabetes Mellitus - Observational Cohort Study of Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Kyunghee University Medical Center:

Primary Outcome Measures:
  • Specific characteristics of Korean type 2 diabetic patients [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    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)


  • Diabetes complications incidence and mortality in Korean type 2 diabetic patients [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    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)


  • Investigation of Korean type 2 diabetic patients' lifestyle [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    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)


  • Economic evaluation of Korean type 2 diabetic patients [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    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)


  • Incidence of diabetes in patients with high risk for diabetes and gestational diabetes in Koreans [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]

    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)



Biospecimen Retention:   Samples With DNA

whole blood, serum, and urine


Estimated Enrollment: 6000
Study Start Date: May 2005
Estimated Study Completion Date: March 2014
Groups/Cohorts
Korean type 2 diabetic patients
Koreans at high risk for diabetes
Korean gestational diabetic patients

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01212198

Contacts
Contact: Young-Seol Kim, MD, PhD +82-2-958-8339 kimys@khmc.or.kr
Contact: Suk Chon, MD, PhD +82-2-958-8843 imdrjs@khu.ac.kr

Locations
Korea, Republic of
Hanyang University Medical Center Recruiting
Kuri, Kyunggi, Korea, Republic of, 471-020
Contact: Yongsoo Park, MD, PhD    +82-31-553-7369    parkys@hanyang.ac.kr   
Principal Investigator: Yongsoo Park, MD, PhD         
Gachon University Gil Hospital Recruiting
In Cheon, Namdong, Korea, Republic of
Contact: Ie-Byung Park, MD, PhD    +82-32-460-3213    park712@gilhospital.com   
Principal Investigator: Ie-Byung Park, MD, PhD         
Yeungnam University Medical Center Recruiting
Daegu, Korea, Republic of, 705-717
Contact: Hyoung Woo Lee, MD, PhD    +82-53-620-3839    helee@med.yu.ac.kr   
Principal Investigator: Hyoung Woo Lee, MD, PhD         
Inha University Hospital Recruiting
In Cheon, Korea, Republic of, 400-711
Contact: Moon-Suk Nam, MD, PhD    +82-32-890-3495    namms@inha.ac.kr   
Principal Investigator: Moon-Suk Nam, MD, PhD         
Pusan National University Hospital Recruiting
Pusan, Korea, Republic of, 602-739
Contact: In-Ju Kim, MD, PhD    +82-51-240-7970    injkim@pusan.ac.kr   
Principal Investigator: In-Ju Kim, MD, PhD         
Kangdong Sacred Heart Hospital Hallym University Recruiting
Seoul, Korea, Republic of, 134-701
Contact: DooMan Kim, MD, PhD    +82-2-2224-2575    dm@hallym.or.kr   
Principal Investigator: DooMan Kim, MD, PhD         
Korea University Guro Hospital Recruiting
Seoul, Korea, Republic of, 152-730
Contact: Sei Hyun Baik, MD, PhD    +82-2-818-6645    103hyun@korea.ac.kr   
Principal Investigator: Sei Hyun Baik, MD, PhD         
Kyunghee University Medical Center Recruiting
Seoul, Korea, Republic of, 130-702
Contact: Young-Seol Kim, MD, PhD    +82-2-958-8339    kimys@khmc.or.kr   
Contact: Suk Chon, MD, PhD    +82-2-958-8843    imdrjs@khu.ac.kr   
Sub-Investigator: Jeong-taek Woo, MD, PhD         
Principal Investigator: Young-Seol Kim, MD, PhD         
Sub-Investigator: Suk Chon, 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         
Inje University Sanggye-Paik Hospital Recruiting
Seoul, Korea, Republic of, 139-707
Contact: Kyung Soo Ko, MD, PhD    +82-2-950-1114    kskomd@sanggyepaik.ac.kr   
Principal Investigator: Kyung Soo Ko, MD, PhD         
Kyung Hee University East West Neo Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyu-Jeung Ahn, MD, PhD    +82-2-440-7055    ahn_kyujeung@yahoo.ca   
Principal Investigator: Kyu-Jeung Ahn, MD, PhD         
Cheil General Hospital Recruiting
Seoul, Korea, Republic of, 100-380
Contact: SungHoon Kim, MD, PhD    +82-2-2000-7271    hoonie.kim@cgh.co.kr   
Principal Investigator: SungHoon Kim, MD, PhD         
Ajou University Medical Center Recruiting
Suwon, Korea, Republic of, 443-721
Contact: Kwan-Woo Lee, MD, PhD    +82-31-219-4526    LKW65@ajou.ac.kr   
Principal Investigator: Kwan-Woo Lee, MD, PhD         
Sponsors and Collaborators
Kyunghee University Medical Center
Korea University Guro Hospital
Hanyang University
Inha University Hospital
Ajou University
East West Neo Medical Center
Pusan National University Hospital
Gachon University Gil Medical Center
Cheil General Hospital and Women’s Healthcare Center
Yeungnam University
Inje University
Kangdong Sacred Heart Hospital
Ministry of Health & Welfare, Korea
Investigators
Principal Investigator: Young-Seol Kim, MD, PhD Kyunghee University Medical Center
  More Information

No publications provided by Kyunghee University Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Young-Seol Kim, MD, PhD, Kyunghee University Medical Center
ClinicalTrials.gov Identifier: NCT01212198     History of Changes
Other Study ID Numbers: KNDP-KMC-0505
Study First Received: September 29, 2010
Last Updated: October 22, 2010
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 23, 2014