Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study

Area of Science:

• Clinical Medicine
• Endocrinology
• Public Health

Background:

• Rising prevalence and disease burden of diabetes mellitus (DM) in Korea necessitate evidence-based prevention strategies.
• Lack of large-scale clinical studies to establish a foundation for diabetes prevention in the Korean population.

Purpose of the Study:

• To gather data for preventing type 2 DM through the hospital-based Korean Diabetes Prevention Study (H-KDPS).
• To compare the effectiveness of standard care, lifestyle modification, and metformin in DM prevention.

Main Methods:

• Prospective, multi-center, randomized, open-label controlled study involving 744 subjects across ten university hospitals.
• Random assignment to standard care, lifestyle modification (≥5% weight loss), or metformin (250-1000 mg/day) groups.
• 36-month observation period with the primary endpoint being the cumulative incidence of DM.

Main Results:

• Intervention methodologies developed and validated by the Korean Diabetes Association (KDA).
• Standard care involves individual education based on KDA guidelines.
• Lifestyle modification group receives professionally guided interventions for weight loss.

Conclusions:

• H-KDPS is the first large-scale clinical study providing evidence-based interventions for type 2 DM prevention in Koreans.
• Findings will aid in enhancing Korean public health and stabilizing the healthcare system.
• Study registered under CRIS KCT0002260 and NCT02981121.