Abstract

Background: The Korean Diabetes Prevention Study (KDPS, NCT02981121), a national clinical study to prevent T2DM, started in 2016 and is currently ongoing. This study was to evaluate the preventive effect of KDPS intervention for up to 1 year. Methods: The enrollment criteria are adults aged 30-70 with a BMI ≥ 23 kg/m2 at high risk of T2DM. Three Intervention methods are hospital-based lifestyle modification (hLSM) developed by Korean Diabetes Association, metformin (MET, 250mg~1000mg) and control standard management (STM) including a visit to the doctor every 6 months. LSM consists of 4 times individual diet interventions and lifestyle modification to keep 10 healthy habits with 7 times on-site and 8 times on phone-call contact. We assessed FPG and A1c every 6 months and OGTT every 12 months to check DM progression. Results: A total of 1611 subjects at 15 university hospitals performed screening with 75g OGTT (KDPS 1: 2016.11 ~ 2018.12, KDPS 2: 2020.9 ~ 2022.4). Eight hundred forty-four patients (male 44.2%) were randomized. The mean age was 56.1 years, BMI 26.6 kg/m2, WC 91.2 cm, FPG 103.2 mg/dL, PP2G 154.9 mg/dL, A1c 5.9%, and there was no significant difference between the three groups. KDPS 2 had a short follow-up period, thus DM prevention effect of up to 1 year was analyzed in 485 subjects of KDPS 1. Up to 1 year, the cumulative incidence of DM was 12/100 person-years (PY) in the LSM, 18/100 PY in MET, and 27/100 PY in STM (P=0.1440). Compared to STM, HR for T2DM in LSM was 0.51 (P=0.0508), and the HR in the MET was 0.82 (P=0.5205). Conclusion: The KDPS was intended to evaluate the DM prevention efficacy of the intervention methods practically applicable in clinical settings in Korea. The hLSM tended to have a 49% DM prevention effect compared to the STM. However, in the case of the MET, there was no significant difference from the control group. Further full analysis of KDPS results is needed for long term effect. Disclosure S.Chon: None. S.Yun: None. J.Woo: None. The korean diabetes prevention study investigators: n/a. Funding Korean Disease Control and Prevention Agency (2020-ER6402-00)

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