Korea National Diabetes Program (KNDP)

October 22, 2010 updated by: Kyunghee University Medical Center

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.

Study Overview

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

Observational

Enrollment (Anticipated)

6000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Young-Seol Kim, MD, PhD
  • Phone Number: +82-2-958-8339
  • Email: kimys@khmc.or.kr

Study Contact Backup

Study Locations

      • Daegu, Korea, Republic of, 705-717
        • Recruiting
        • Yeungnam University Medical Center
        • Contact:
        • Principal Investigator:
          • Hyoung Woo Lee, MD, PhD
      • In Cheon, Korea, Republic of, 400-711
        • Recruiting
        • Inha University Hospital
        • Contact:
        • Principal Investigator:
          • Moon-Suk Nam, MD, PhD
      • Pusan, Korea, Republic of, 602-739
        • Recruiting
        • Pusan National University Hospital
        • Contact:
        • 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:
        • Contact:
        • 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:
        • Principal Investigator:
          • SungHoon Kim, MD, PhD
      • Seoul, Korea, Republic of, 134-701
        • Recruiting
        • Kangdong Sacred Heart Hospital Hallym University
        • Contact:
        • Principal Investigator:
          • DooMan Kim, MD, PhD
      • Seoul, Korea, Republic of, 139-707
        • Recruiting
        • Inje University Sanggye-Paik Hospital
        • Contact:
        • Principal Investigator:
          • Kyung Soo Ko, MD, PhD
      • Seoul, Korea, Republic of, 152-730
        • Recruiting
        • Korea University Guro Hospital
        • Contact:
        • Principal Investigator:
          • Sei Hyun Baik, MD, PhD
      • Seoul, Korea, Republic of
        • Recruiting
        • Kyung Hee University East West Neo Medical Center
        • Contact:
        • Principal Investigator:
          • Kyu-Jeung Ahn, MD, PhD
      • Suwon, Korea, Republic of, 443-721
        • Recruiting
        • Ajou University Medical Center
        • Contact:
        • Principal Investigator:
          • Kwan-Woo Lee, MD, PhD
    • Kyunggi
      • Kuri, Kyunggi, Korea, Republic of, 471-020
        • Recruiting
        • Hanyang University Medical Center
        • Contact:
        • Principal Investigator:
          • Yongsoo Park, MD, PhD
    • Namdong
      • In Cheon, Namdong, Korea, Republic of
        • Recruiting
        • Gachon University Gil Hospital
        • Contact:
        • Principal Investigator:
          • Ie-Byung Park, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Study Completion (Anticipated)

March 1, 2014

Study Registration Dates

First Submitted

September 29, 2010

First Submitted That Met QC Criteria

September 29, 2010

First Posted (Estimate)

September 30, 2010

Study Record Updates

Last Update Posted (Estimate)

October 25, 2010

Last Update Submitted That Met QC Criteria

October 22, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

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.

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