Korea National Diabetes Program (KNDP)

Kyung Hee University

Status: Unknown

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

Study type: Observational

Funder types: Other

Identifiers

NCT01212198

KNDP-KMC-0505

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6,000 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

6,000 participants in 3 patient groups

Korean type 2 diabetic patients

Koreans at high risk for diabetes

Korean gestational diabetic patients