Linong Ji1, Ningling Sun1, Yunliang Zhang2, Lihui Zhang3, Sheng'ai Shen4, Xueying Wang5, Qiuyun Li6, Luling Dong7, Weidong Ren8, Lin Qi9, Yufeng Li10, Shuang Yan11, Wenli Cheng12, Hongyu Kuang13, Guangwei Li14. 1. Department of Endocrinology and Metabolism, Peking University People's Hospital, Beijing, China. 2. Department of Endocrinology and Metabolism, Baoding First Central Hospital, Baoding, Hebei, China. 3. Department of Endocrinology and Metabolism, The Second Hospital of Hebei Medical University, Shijiazhuang, Hebei, China. 4. Department of Endocrinology and Metabolism, Yanji Hospital, Yanji, Yanbian Korean Autonomous Prefecture, Jilin, China. 5. Department of Endocrinology and Metabolism, Jinzhou Central Hospital, Jinzhou, Liaoning, China. 6. Department of Endocrinology and Metabolism, Kailuan General Hospital, Tangshan, Hebei Province, China. 7. Department of Endocrinology and Metabolism, Zhangjiakou First Hospital, Zhangjiakou, Hebei, China. 8. Department of Endocrinology and Metabolism, First Affiliated Hospital of Hebei North University, Zhangjiakou, Hebei, China. 9. Department of Endocrinology and Metabolism, Beijing Yanhua Hospital, Beijing, China. 10. Department of Endocrinology and Metabolism, Beijing Pinggu Hospital, Beijing, China. 11. Department of Endocrinology and Metabolism, Fourth Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China. 12. Department of Hypertension, Beijing Anzhen Hospital, Beijing, China. 13. Department of Endocrinology and Metabolism, First Affiliated Hospital of Harbin Medical University, Harbin, Heilongjiang, China. 14. Department of Endocrinology, Fuwai Hospital & Chinese Academy of Medical Sciences, Beijing, China.
Abstract
AIM: To investigate the effectiveness of metformin in delaying or preventing progression to diabetes in a Chinese population with impaired glucose regulation (IGR). MATERIALS AND METHODS: This multicentre, randomized, open-label, controlled study (NCT03441750) will assess the efficacy of metformin in preventing diabetes over ≥2 years. Eligible participants will be randomly assigned (1:1) to lifestyle intervention (LSI) or metformin plus LSI, with stratification based on blood pressure, anti-hypertensive medication use and isolated/non-isolated impaired fasting glucose. All participants will receive LSI advice. Participants in the metformin plus LSI group will receive metformin 850 mg once daily for the first 2 weeks, and twice daily thereafter, according to tolerability. RESULTS: The primary objective is to compare rates of newly diagnosed diabetes in the two intervention groups. Changes in glycaemia, blood pressure, body weight, insulin resistance, and safety outcomes will also be evaluated. CONCLUSIONS: This large clinical trial in a Chinese population with IGR aims to provide critical information to guide clinical decision-making in order to alleviate the current diabetes epidemic.
RCT Entities:
AIM: To investigate the effectiveness of metformin in delaying or preventing progression to diabetes in a Chinese population with impaired glucose regulation (IGR). MATERIALS AND METHODS: This multicentre, randomized, open-label, controlled study (NCT03441750) will assess the efficacy of metformin in preventing diabetes over ≥2 years. Eligible participants will be randomly assigned (1:1) to lifestyle intervention (LSI) or metformin plus LSI, with stratification based on blood pressure, anti-hypertensive medication use and isolated/non-isolated impaired fasting glucose. All participants will receive LSI advice. Participants in the metformin plus LSI group will receive metformin 850 mg once daily for the first 2 weeks, and twice daily thereafter, according to tolerability. RESULTS: The primary objective is to compare rates of newly diagnosed diabetes in the two intervention groups. Changes in glycaemia, blood pressure, body weight, insulin resistance, and safety outcomes will also be evaluated. CONCLUSIONS: This large clinical trial in a Chinese population with IGR aims to provide critical information to guide clinical decision-making in order to alleviate the current diabetes epidemic.
Authors: Luis A Rodríguez; Simón Barquera; Carlos A Aguilar-Salinas; Jaime Sepúlveda-Amor; Luz María Sánchez-Romero; Edgar Denova-Gutiérrez; Nydia Balderas; Lizbeth Moreno-Loaeza; Margaret A Handley; Sanjay Basu; Oliva López-Arellano; Alberto Gallardo-Hernández; Dean Schillinger Journal: Contemp Clin Trials Date: 2020-06-21 Impact factor: 2.226