Clinical trial NCT01212198: Korea National Diabetes Program
Official title: Clinical Research Center For Type 2 Diabetes Mellitus - Observational Cohort Study of Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 2 Diabetes Mellitus
Diagnosis
Treatment
Prevention
Complications
Lead sponsor: Kyunghee University Medical Center
Sponsor class: OTHER
Collaborators: name: Korea University Guro Hospital
name: Hanyang University
name: Inha University Hospital
name: Ajou University
name: East West Neo Medical Center
name: Pusan National University Hospital
name: Gachon University Gil Medical Center
name: Cheil General Hospital and Women's Healthcare Center
name: Yeungnam University Hospital
name: Inje University
name: Kangdong Sacred Heart Hospital
name: Ministry of Health & Welfare, Korea
First posted: 2010-09-30
Enrollment: 6000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with type 2 diabetes, Koreans at high risk for diabetes, Korean patients with gestational diabetes

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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Specific characteristics of Korean type 2 diabetic patients
timeFrame: up to 10 years
measure: Diabetes complications incidence and mortality in Korean type 2 diabetic patients
timeFrame: up to 10 years
measure: Investigation of Korean type 2 diabetic patients' lifestyle
timeFrame: up to 10 years
measure: Economic evaluation of Korean type 2 diabetic patients
timeFrame: up to 10 years
measure: Incidence of diabetes in patients with high risk for diabetes and gestational diabetes in Koreans
timeFrame: up to 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kuri
country: Korea, Republic of
facility: Hanyang University Medical Center
state: Kyunggi
city: In Cheon
country: Korea, Republic of
facility: Gachon University Gil Hospital
state: Namdong
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: In Cheon
country: Korea, Republic of
facility: Inha University Hospital
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital Hallym University
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye-Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University East West Neo Medical Center
city: Suwon
country: Korea, Republic of
facility: Ajou University Medical Center
Study officials:
affiliation: Kyunghee University Medical Center
name: Young-Seol Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SH, Hong SB, Suh YJ, Choi YJ, Nam M, Lee HW, Park IeB, Chon S, Woo JT, Baik SH, Park Y, Kim DJ, Lee KW, Kim YS; KNDP Study Group. Association between nutrient intake and obesity in type 2 diabetic patients from the Korean National Diabetes Program: a cross-sectional study. J Korean Med Sci. 2012 Oct;27(10):1188-95. doi: 10.3346/jkms.2012.27.10.1188. Epub 2012 Oct 2.
citation: Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.