Korea National Diabetes Program

• Conditions: Type 2 Diabetes Mellitus; Prevention; Complications; Diagnosis; Treatment

• Registration Number: NCT01212198
• Lead Sponsor: Kyunghee University Medical Center

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.

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 Timeline

• Study Start: 2005-05
• Status Verified: 2010-09
• Study First Submitted: 2010-09-29
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25
• Study Completion: 2014-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Specific characteristics of Korean type 2 diabetic patients	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)
Investigation of Korean type 2 diabetic patients' lifestyle	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)
Economic evaluation of Korean type 2 diabetic patients	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)
Diabetes complications incidence and mortality in Korean type 2 diabetic patients	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)
Incidence of diabetes in patients with high risk for diabetes and gestational diabetes in Koreans	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)

Trial Locations

Locations (12)

Hanyang University Medical Center; 🇰🇷 Kuri, Kyunggi, Korea, Republic of

Pusan National University Hospital; 🇰🇷 Pusan, Korea, Republic of

Kyunghee University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Sanggye-Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Gachon University Gil Hospital; 🇰🇷 In Cheon, Namdong, Korea, Republic of

Ajou University Medical Center; 🇰🇷 Suwon, Korea, Republic of

Cheil General Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital Hallym University; 🇰🇷 Seoul, Korea, Republic of

Korea University Guro Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyung Hee University East West Neo Medical Center; 🇰🇷 Seoul, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inha University Hospital; 🇰🇷 In Cheon, Korea, Republic of