Korea National Diabetes Program

Type 2 Diabetes Mellitus Clinical Trial

— KNDP  

Official title:

Clinical Research Center For Type 2 Diabetes Mellitus - Observational Cohort Study of Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01212198
• Other study ID #: KNDP-KMC-0505
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2010
• Last updated: October 22, 2010
• Start date: May 2005
• Est. completion date: March 2014

Study information

• Verified date: September 2010
• Source: Kyunghee University Medical Center
• Contact: Young-Seol Kim, MD, PhD
• Phone: +82-2-958-8339
• Email: kimys[@]khmc.or.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Complications
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diagnosis
• Prevention
• Treatment
• Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Gachon University Gil Hospital	In Cheon	Namdong
Korea, Republic of	Inha University Hospital	In Cheon
Korea, Republic of	Hanyang University Medical Center	Kuri	Kyunggi
Korea, Republic of	Pusan National University Hospital	Pusan
Korea, Republic of	Cheil General Hospital	Seoul
Korea, Republic of	Inje University Sanggye-Paik 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	Kyunghee University Medical Center	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon

Sponsors (13)

Lead Sponsor	Collaborator
Kyunghee University Medical Center	Ajou University, Cheil General Hospital and Women’s Healthcare Center, East West Neo Medical Center, Gachon University Gil Medical Center, Hanyang University, Inha University Hospital, Inje University, Kangdong Sacred Heart Hospital, Korea University Guro Hospital, Ministry of Health & Welfare, Korea, Pusan National University Hospital, Yeungnam University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Specific characteristics of Korean type 2 diabetic patients	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	No
Primary	Diabetes complications incidence and mortality in Korean type 2 diabetic patients	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	No
Primary	Investigation of Korean type 2 diabetic patients' lifestyle	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	No
Primary	Economic evaluation of Korean type 2 diabetic patients	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	No
Primary	Incidence of diabetes in patients with high risk for diabetes and gestational diabetes in Koreans	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	No