DataSheet_1_Probiotics intervention in preventing conversion of impaired glucose tolerance to diabetes: The PPDP follow-on study.doc

ObjectivesThe purpose of this study was to assess the incidence of type 2 diabetes mellitus (T2DM) after 6 years in patients with IGT who received early probiotic intervention in the Probiotics Prevention Diabetes Program (PPDP) trial.Methods77 patients with IGT in the PPDP trial were randomized to either probiotic or placebo. After the completion of the trial, 39 non-T2DM patients were invited to follow up glucose metabolism after the next 4 years. The incidence of T2DM in each group was assessed using Kaplan-Meier analysis. The 16S rDNA sequencing technology was used to analyze gut microbiota’s structural composition and abundance changes between the groups.ResultsThe cumulative incidence of T2DM was 59.1% with probiotic treatment versus 54.5% with placebo within 6 years, there was no significant difference in the risk of developing T2DM between the two groups (P=0.674).ConclusionsSupplemental probiotic therapy does not reduce the risk of IGT conversion to T2DM.Clinical Trial Registrationhttps://www.chictr.org.cn/showproj.aspx?proj=5543, identifier ChiCTR-TRC-13004024.

本研究旨在评估在普罗比otic预防糖尿病计划（PPDP）试验中接受早期普罗比otic干预的糖耐量低减（IGT）患者在接受干预6年后的2型糖尿病（T2DM）发病率。研究方法中，77名PPDP试验中的IGT患者被随机分配接受普罗比otic或安慰剂。试验完成后，39名非T2DM患者被邀请在接下来的4年内进行葡萄糖代谢的随访。采用Kaplan-Meier分析评估了两组中T2DM的发病率。利用16S rDNA测序技术分析了两组之间肠道微生物群的结构组成和丰度变化。研究结果发现，接受普罗比otic治疗组的T2DM累积发病率为59.1%，而安慰剂组的累积发病率为54.5%，两组间发生T2DM的风险无显著差异（P=0.674）。结论表明，补充普罗比otic疗法并不能降低IGT转化为T2DM的风险。临床试验注册信息：https://www.chictr.org.cn/showproj.aspx?proj=5543，标识符ChiCTR-TRC-13004024。