Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

September 29, 2010
October 22, 2010
May 2005
Not Provided
  • 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)

Same as current
Complete list of historical versions of study NCT01212198 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Korea National Diabetes Program
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

whole blood, serum, and urine

Probability Sample

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

  • Type 2 Diabetes Mellitus
  • Diagnosis
  • Treatment
  • Prevention
  • Complications
Not Provided
  • Korean type 2 diabetic patients
  • Koreans at high risk for diabetes
  • Korean gestational diabetic patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
6000
March 2014
Not Provided

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:

-

Both
20 Years and older
No
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
Korea, Republic of
 
NCT01212198
KNDP-KMC-0505
Yes
Young-Seol Kim, MD, PhD, Kyunghee University Medical Center
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
Principal Investigator: Young-Seol Kim, MD, PhD Kyunghee University Medical Center
Kyunghee University Medical Center
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP