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Randomized Controlled Trial
. 2019 Feb;43(1):49-58.
doi: 10.4093/dmj.2018.0033. Epub 2018 Nov 2.

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

Sang Youl Rhee  1 , Suk Chon  1 , Kyu Jeung Ahn  1 , Jeong Taek Woo  2 ; Korean Diabetes Prevention Study Investigators
Affiliations
Randomized Controlled Trial

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

Sang Youl Rhee et al. Diabetes Metab J. 2019 Feb.

Abstract

Background: 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.

Methods: 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.

Results: 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.

Conclusion: 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).

Keywords: Clinical trial; Diabetes mellitus, type 2; Early intervention (education); Life style; Metformin; Prediabetic state; Primary prevention; Risk reduction behavior.

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Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Fig. 1
Fig. 1. Organization chart of Korean Diabetes Prevention Study Steering Committee.
Fig. 2
Fig. 2. Korean Diabetes Prevention Study (KDPS) study design.
See this image and copyright information in PMC

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