Zhu Xiaxuan, Xia Li, Yin Deshan, Yang Jin, Wei Rui
Department of Endocrinology and Metabolism, National Clinical Research Center for Obstetrics and Gynecology, Peking University Third Hospital, Beijing, 100191, China.
Diabetes Ther. 2024 May;15(5):1231-1244. doi: 10.1007/s13300-024-01560-3. Epub 2024 Mar 18.
Prediabetes is a state of subclinical glycemic impairment, bridging normal glucose tolerance and diabetes. Globally, over 30% of individuals exhibit prediabetic conditions, with a significant proportion progressing to diabetes. Prediabetes augments risks of various diseases including cardiovascular and kidney disease. While interventions like lifestyle changes have shown promise in diabetes prevention, their long-term sustainability is challenging. Alternative pharmacological treatments, such as acarbose and metformin, have demonstrated efficacy in certain populations. Sodium-glucose co-transporter 2 inhibitors, a novel class of glucose-lowering agents, have shown potential benefits for heart and kidney health in patients with diabetes. This research aims to evaluate the effectiveness and safety of dapagliflozin in individuals with prediabetes, elucidating its potential role in diabetes prevention strategies.
This prospective trial is being conducted at Peking University Third Hospital. A total of 240 participants with prediabetes will be enrolled and randomly divided into two groups: one receiving dapagliflozin (10 mg/day) with lifestyle education, and the other with lifestyle education alone over a 12-week duration (with male/female = 1:1 in each group). Anthropometric, clinical and laboratory tests, including body mass index, waist circumference, fasting blood glucose, oral glucose tolerance test, insulin, lipid profile, liver and kidney function, sperm quality, will be conducted at the onset and conclusion of the trial. For adherence monitoring, participants will receive phone follow-ups at week 4 and week 8. The primary outcome is the change in 2-h plasma glucose during an oral glucose tolerance test over the study duration. Secondary outcomes encompass changes in various health metrics, including body mass index, lipid profiles, and liver function.
The proposed study is set to refine diabetes prevention strategies on the basis of its potential benefits observed in patients with diabetes.
This will be the first randomized controlled trial to evaluate the safety and effectiveness of sodium-glucose co-transporter 2 inhibitors compared with lifestyle education for individuals with prediabetes.
ClinicalTrials.gov identifier NCT05914857 (registered 24 July 2023).
糖尿病前期是一种亚临床血糖受损状态，介于正常糖耐量和糖尿病之间。在全球范围内，超过30%的个体存在糖尿病前期状况，其中很大一部分会发展为糖尿病。糖尿病前期会增加包括心血管疾病和肾脏疾病在内的各种疾病的风险。虽然生活方式改变等干预措施在糖尿病预防方面已显示出前景，但其长期可持续性具有挑战性。阿卡波糖和二甲双胍等替代药物治疗在某些人群中已证明有效。钠-葡萄糖协同转运蛋白2抑制剂是一类新型降糖药物，已显示出对糖尿病患者心脏和肾脏健康的潜在益处。本研究旨在评估达格列净在糖尿病前期个体中的有效性和安全性，阐明其在糖尿病预防策略中的潜在作用。
这项前瞻性试验正在北京大学第三医院进行。总共将招募240名糖尿病前期参与者，并随机分为两组：一组接受达格列净（10毫克/天）并接受生活方式教育，另一组仅接受生活方式教育，为期12周（每组男女比例为1:1）。在试验开始和结束时将进行人体测量、临床和实验室检查，包括体重指数、腰围、空腹血糖、口服葡萄糖耐量试验、胰岛素、血脂谱、肝肾功能、精子质量。为了监测依从性，将在第4周和第8周对参与者进行电话随访。主要结局是研究期间口服葡萄糖耐量试验中2小时血浆葡萄糖的变化。次要结局包括各种健康指标的变化，包括体重指数、血脂谱和肝功能。
拟进行的研究旨在根据在糖尿病患者中观察到的潜在益处完善糖尿病预防策略。
这将是第一项评估钠-葡萄糖协同转运蛋白2抑制剂与生活方式教育相比对糖尿病前期个体的安全性和有效性的随机对照试验。
ClinicalTrials.gov标识符NCT05914857（2023年7月24日注册）
