A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes

Aims. Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored wheth...

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Main Authors: Yingying Luo, Hongyuan Wang, Xianghai Zhou, Cuiqing Chang, Wei Chen, Xiaohui Guo, Jinkui Yang, Linong Ji, Sanjoy K. Paul
Format: Article
Language:English
Published: Wiley 2022-01-01
Series:Journal of Diabetes Research
Online Access:http://dx.doi.org/10.1155/2022/2971382
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author Yingying Luo
Hongyuan Wang
Xianghai Zhou
Cuiqing Chang
Wei Chen
Xiaohui Guo
Jinkui Yang
Linong Ji
Sanjoy K. Paul
author_facet Yingying Luo
Hongyuan Wang
Xianghai Zhou
Cuiqing Chang
Wei Chen
Xiaohui Guo
Jinkui Yang
Linong Ji
Sanjoy K. Paul
author_sort Yingying Luo
collection DOAJ
description Aims. Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. Materials and Methods. We conducted a randomized, multicenter, 2×2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. Results. In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. Conclusion. In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.
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spelling doaj-art-9341df1ed68143688548e07b942d524e2025-02-03T05:54:30ZengWileyJournal of Diabetes Research2314-67532022-01-01202210.1155/2022/2971382A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with PrediabetesYingying Luo0Hongyuan Wang1Xianghai Zhou2Cuiqing Chang3Wei Chen4Xiaohui Guo5Jinkui Yang6Linong Ji7Sanjoy K. Paul8Department of Endocrinology and MetabolismDepartment of Epidemiology and BiostatisticsDepartment of Endocrinology and MetabolismInstitute of Sports MedicineDepartment of Parenteral and Enteral NutritionDepartment of Endocrinology and MetabolismDepartment of Endocrinology and MetabolismDepartment of Endocrinology and MetabolismMelbourne EpiCentreAims. Prediabetes has been proved as an important risk factor of both diabetes and cardiovascular disease (CVD). Previous studies have shown that both lifestyle intervention and pioglitazone may delay the development of diabetes in patients with prediabetes. However, no study has ever explored whether these interventions could revert prediabetes to normal glycemic status as the primary outcome. Interventions that may revert prediabetes back to normal glucose status would be of great clinical importance. Materials and Methods. We conducted a randomized, multicenter, 2×2 factorial designed study to examine whether intensive lifestyle intervention and/or pioglitazone could revert prediabetes to normal glucose tolerance. The participants were followed up for three years unless they reverted to normal glucose state or developed diabetes at the annual oral glucose tolerance test (OGTT). Reversion to normal glucose tolerance was confirmed on the basis of the results of OGTT. Results. In our study, 1945 eligible patients were ultimately randomized into four groups. In this three-year follow-up study, overall, 60.0%, 50.3%, 56.6% and 65.1% reverted back to normoglycemic state over 3 years of follow-up in the conventional lifestyle intervention plus placebo, intensive lifestyle intervention plus placebo, conventional lifestyle intervention plus pioglitazone, and intensive lifestyle intervention plus pioglitazone groups, respectively. Compared to the conventional lifestyle intervention plus placebo group, all the other three groups did not show any significant benefit in terms of reverting back to normoglycemic state. Conclusion. In our study, for patients with prediabetes, neither intensive lifestyle intervention nor pioglitazone had led to a higher reversion rate to normal glucose state. Trail registration.http://www.chictr.org.cn: ChiCTR-PRC-06000005.http://dx.doi.org/10.1155/2022/2971382
spellingShingle Yingying Luo
Hongyuan Wang
Xianghai Zhou
Cuiqing Chang
Wei Chen
Xiaohui Guo
Jinkui Yang
Linong Ji
Sanjoy K. Paul
A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
Journal of Diabetes Research
title A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
title_full A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
title_fullStr A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
title_full_unstemmed A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
title_short A Randomized Controlled Clinical Trial of Lifestyle Intervention and Pioglitazone for Normalization of Glucose Status in Chinese with Prediabetes
title_sort randomized controlled clinical trial of lifestyle intervention and pioglitazone for normalization of glucose status in chinese with prediabetes
url http://dx.doi.org/10.1155/2022/2971382
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