Kassaian Nazila, Aminorroaya Ashraf, Feizi Awat, Jafari Parvaneh, Amini Masoud
Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.
Biostatistics and Epidemiology Department, School of Health, Cardiac Rehabilitation Research Center, Isfahan Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.
Trials. 2017 Mar 29;18(1):148. doi: 10.1186/s13063-017-1885-8.
The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has emerged as a new candidate that may be linked to metabolic diseases. We hypothesize that selective modulation of the intestinal microbiota by probiotic or synbiotic supplementation may improve metabolic dysfunction and prevent diabetes in prediabetics. In this study, a synthesis and study of synbiotics will be carried out for the first time in Iran.
METHODS/DESIGN: In a randomized triple-blind controlled clinical trial, 120 adults with impaired glucose tolerance based on the inclusion criteria will be selected by a simple random sampling method and will be randomly allocated to 6 months of 6 g/d probiotic, synbiotic or placebo. The fecal abundance of bacteria, blood pressure, height, weight, and waist and hip circumferences will be measured at baseline and following treatment. Also, plasma lipid profiles, HbA1C, fasting plasma glucose, and insulin levels, will be measured and insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) will be calculated at baseline and will be repeated at months 3, 6, 12, and 18. The data will be compared within and between groups using statistical methods.
The results of this trial could contribute to the evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in prevention and management of metabolic syndrome in prediabetes.
Iranian Registry of Clinical Trials: IRCT201511032321N2 . Registered on 27 February 2016.
2型糖尿病、心血管疾病和肥胖症的发病率一直在急剧上升；然而，它们的发病机制特别引人关注。最近，肠道微生物群失调已成为一种可能与代谢性疾病相关的新因素。我们假设，通过补充益生菌或合生元对肠道微生物群进行选择性调节，可能会改善代谢功能障碍，并预防糖尿病前期患者患糖尿病。在本研究中，将在伊朗首次开展合生元的合成与研究。
方法/设计：在一项随机三盲对照临床试验中，将通过简单随机抽样方法选择120名符合纳入标准的糖耐量受损成年人，并将他们随机分配，分别接受为期6个月、每日6克的益生菌、合生元或安慰剂治疗。在基线期和治疗后，将测量粪便细菌丰度、血压、身高、体重以及腰围和臀围。此外，还将测量血脂谱、糖化血红蛋白（HbA1C）、空腹血糖和胰岛素水平，并在基线期计算胰岛素抵抗（HOMA-IR）和β细胞功能（HOMA-B），并在第3、6、12和18个月重复测量。将使用统计方法对组内和组间的数据进行比较。
该试验结果可能有助于形成循证临床指南，这些指南涉及通过操控肠道微生物群，在糖尿病前期患者预防和管理代谢综合征方面实现最大程度的健康效益。
伊朗临床试验注册中心：IRCT201511032321N2。于2016年2月27日注册。
