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The prevalence of diabetes mellitus (DM) continues to increase, and the disease burden is the highest of any medical condition in Korea. However, large-scale clinical studies have not yet conducted to establish the basis for diabetes prevention in Korea.
The hospital-based Korean Diabetes Prevention Study (H-KDPS) is a prospective, multi-center, randomized, open-label controlled study conducted at university hospitals for the purpose of gathering data to help in efforts to prevent type 2 DM. Ten university hospitals are participating, and 744 subjects will be recruited. The subjects are randomly assigned to the standard care group, lifestyle modification group, or metformin group, and their clinical course will be observed for 36 months.
All intervention methodologies were developed, validated, and approved by Korean Diabetes Association (KDA) multi-disciplinary team members. The standard control group will engage in individual education based on the current KDA guidelines, and the lifestyle modification group will participate in a professionally guided healthcare intervention aiming for ≥5% weight loss. The metformin group will begin dosing at 250 mg/day, increasing to a maximum of 1,000 mg/day. The primary endpoint of this study is the cumulative incidence of DM during the 3 years after randomization.
The H-KDPS study is the first large-scale clinical study to establish evidence-based interventions for the prevention of type 2 DM in Koreans. The evidence gathered by this study will be useful for enhancing the health of Koreans and improving the stability of the Korean healthcare system (Trial registration: CRIS KCT0002260, NCT02981121).
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In Korea, a person with a body mass index (BMI) ≥25 kg/m2 is considered obese, and a person with a BMI ≥30 kg/m2 is classified as severely obese. Central obesity is defined as a waist circumference ≥90 cm for Korean men and ≥85 cm for Korean women. Recent epidemiologic data show that the prevalence of severe obesity and metabolic syndrome is steadily increasing. These epidemics increased morbidity and mortality of type 2 diabetes, cardiovascular diseases, and obesity-related cancers such as breast, colorectal, and other cancers in Korea. Decreased physical activity, increased fat and alcohol consumption, heavy smoking, and stress/depressed mood are the primary modifiable life-style risk factors for Koreans. Recently, public health interventions to encourage life-style changes have shown promising results in reducing the prevalence of severe obesity and metabolic syndrome.
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