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
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 li...
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| Format: | Article |
| Language: | English |
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Wiley
2017-01-01
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| Series: | Journal of Diabetes Research |
| Online Access: | http://dx.doi.org/10.1155/2017/7602408 |
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| author | Yingying Luo Sanjoy K. Paul Xianghai Zhou Cuiqing Chang Wei Chen Xiaohui Guo Jinkui Yang Linong Ji Hongyuan Wang |
| author_facet | Yingying Luo Sanjoy K. Paul Xianghai Zhou Cuiqing Chang Wei Chen Xiaohui Guo Jinkui Yang Linong Ji Hongyuan Wang |
| author_sort | Yingying Luo |
| collection | DOAJ |
| description | 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 53±10 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. |
| format | Article |
| id | doaj-art-9ed2f0023a8547e98063d27667ee16b1 |
| institution | Kabale University |
| issn | 2314-6745 2314-6753 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Research |
| spelling | doaj-art-9ed2f0023a8547e98063d27667ee16b12025-02-03T01:03:01ZengWileyJournal of Diabetes Research2314-67452314-67532017-01-01201710.1155/2017/76024087602408Rationale, 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 PrediabetesYingying Luo0Sanjoy K. Paul1Xianghai Zhou2Cuiqing Chang3Wei Chen4Xiaohui Guo5Jinkui Yang6Linong Ji7Hongyuan Wang8Department of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, ChinaMelbourne EpiCentre, University of Melbourne, Melbourne, VIC, AustraliaDepartment of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, ChinaInstitute of Sports Medicine, Peking University Third Hospital, Beijing, ChinaDepartment of Parenteral and Enteral Nutrition, Peking Union Medical College Hospital, Beijing, ChinaDepartment of Endocrinology and Metabolism, Peking University First Hospital, Beijing, ChinaDepartment of Endocrinology and Metabolism, Beijing Tongren Hospital, Capital Medical University, Beijing, ChinaDepartment of Endocrinology and Metabolism, Peking University People’s Hospital, Beijing, ChinaDepartment of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, ChinaBackground. 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 53±10 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.http://dx.doi.org/10.1155/2017/7602408 |
| spellingShingle | Yingying Luo Sanjoy K. Paul Xianghai Zhou Cuiqing Chang Wei Chen Xiaohui Guo Jinkui Yang Linong Ji Hongyuan Wang 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 Journal of Diabetes Research |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2017/7602408 |
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