Subject    :    [2019 Feb;43(1)] Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study
Writer KDA
Date 2019-03-06 10:19:18 Hit 82
Diabetes Metab J. 2019 Feb;43(1):49-58. English.
Published online Nov 02, 2018.  https://doi.org/10.4093/dmj.2018.0033 
Copyright © 2018 Korean Diabetes Association
   
Hospital-Based Korean Diabetes Prevention Study: A Prospective, Multi-Center, Randomized, Open-Label Controlled Study
Sang Youl Rhee, Suk Chon, Kyu Jeung Ahn, Jeong-Taek Woo, and the Korean Diabetes Prevention Study Investigators
Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, Seoul, Korea.

Corresponding author: Jeong-Taek Woo. Department of Endocrinology and Metabolism, Kyung Hee University School of Medicine, 23 Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea. Email: jtwoomd@khmc.or.kr 
 
Received February 18, 2018; Accepted June 03, 2018.

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

 
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:
Diabetes mellitus, type 2Clinical trialEarly intervention (education)Life style; MetforminPrediabetic statePrimary preventionRisk reduction behavior

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