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Journal of Diabetes Research
Volume 2017 (2017), Article ID 7602408, 11 pages
https://doi.org/10.1155/2017/7602408
Clinical Study

Rationale, Design, and Baseline Characteristics of Beijing Prediabetes Reversion Program: A Randomized Controlled Clinical Trial to Evaluate the Efficacy of Lifestyle Intervention and/or Pioglitazone in Reversion to Normal Glucose Tolerance in Prediabetes

1Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, China
2Melbourne EpiCentre, University of Melbourne, Melbourne, VIC, Australia
3Clinical Trials and Biostatistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia
4Institute of Sports Medicine, Peking University Third Hospital, Beijing, China
5Department of Parenteral and Enteral Nutrition, Peking Union Medical College Hospital, Beijing, China
6Department of Endocrinology and Metabolism, Peking University First Hospital, Beijing, China
7Department of Endocrinology and Metabolism, Beijing Tongren Hospital, Capital Medical University, Beijing, China
8Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China

Correspondence should be addressed to Linong Ji; nc.ude.umjb@nlij and Hongyuan Wang; moc.361@3002w_yhw

Received 24 October 2016; Accepted 28 November 2016; Published 12 January 2017

Academic Editor: Ruozhi Zhao

Copyright © 2017 Yingying Luo et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background. Patients with prediabetes are at high risk for diabetes and cardiovascular disease (CVD). No study has explored whether intervention could revert prediabetes to normal glycemic status as the primary outcome. Beijing Prediabetes Reversion Program (BPRP) would evaluate whether intensive lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia and improve the risk factors of CVD as well. Methods. BPRP is a randomized, multicenter, 2 × 2 factorial design study. Participants diagnosed as prediabetes were randomized into four groups (conventional/intensive lifestyle intervention and 30 mg pioglitazone/placebo) with a three-year follow-up. The primary endpoint was conversion into normal glucose tolerance. The trial would recruit 2000 participants (500 in each arm). Results. Between March 2007 and March 2011, 1945 participants were randomized. At baseline, the individuals were years old, with median BMI 26.0 (23.9, 28.2) kg/m2 and HbA1c 5.8 (5.6, 6.1)%. 85% of the participants had IGT and 15% had IFG. Parameters relevant to glucose, lipids, blood pressure, lifestyle, and other metabolic markers were similar between conventional and intensive lifestyle intervention group at baseline. Conclusion. BPRP was the first study to determine if lifestyle modification and/or pioglitazone could revert prediabetic state to normoglycemia in Chinese population. Major baseline parameters were balanced between two lifestyle intervention groups. This trial is registered with www.chictr.org.cn: ChiCTR-PRC-06000005.