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 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/m2and 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.
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Yingying
Y
Luo
Melbourne EpiCentre, University of Melbourne, Melbourne, VIC, Australia; Clinical Trials and Biostatistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, QLD, Australia.
Sanjoy K
SK
Paul
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Xianghai
X
Zhou
Institute of Sports Medicine, Peking University Third Hospital, Beijing, China.
Cuiqing
C
Chang
Department of Parenteral and Enteral Nutrition, Peking Union Medical College Hospital, Beijing, China.
Wei
0000-0003-4403-8089
W
Chen
Department of Endocrinology and Metabolism, Peking University First Hospital, Beijing, China.
Xiaohui
X
Guo
Department of Endocrinology and Metabolism, Beijing Tongren Hospital, Capital Medical University, Beijing, China.
Jinkui
J
Yang
Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China.
Linong
0000-0003-1305-1598
L
Ji
Department of Epidemiology and Biostatistics, School of Public Health, Peking University Health Science Center, Beijing, China.
Hongyuan
0000-0002-9330-5940
H
Wang
D000328:Adult; D001786:Blood Glucose / Q000378:metabolism*; D002985:Clinical Protocols; D005260:Female; D018149:Glucose Intolerance / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008019:Life Style; D008297:Male; D008875:Middle Aged; D000077205:Pioglitazone; D011236:Prediabetic State / Q000097:blood / Q000188:drug therapy / Q000628:therapy*; D012107:Research Design; D040242:Risk Reduction Behavior; D045162:Thiazolidinediones / Q000627:therapeutic use*; D016896:Treatment Outcome
D001786:Blood Glucose; D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077205:Pioglitazone