Multiple dietary fiber for gestational hyperinsulinism A protocol of systematic review and meta-analysis of randomized clinical trials

Introduction: Gestational hyperinsulinism is a metabolic disease which is widely concerned at home and abroad. It is a clinical consensus that the embryo implantation ability of patients with hyperinsulinemia is decreased and the abortion rate after implantation is high. The treatment of gestational hyperinsulinism with Multiple dietary fiber diets has been proven. However, due to the lack of evidence, there is no specific method or recommendation, it is necessary to carry out a systematic evaluation of Multiple dietary fiber diet, to provide effective evidence for further research. Methods and analysis: The following databases will be searched from their inception to August 2020: Electronic database includes PubMed, Embase, Cochrane Library, Web of Science, Nature, Science online, Chinese Biomedical Database WanFang, VIP medicine information, and CNKI. Primary outcomes: Fasting glucose, fasting insulin, homeostasis model assessment of insulin resistance, glycosylated hemoglobin. Additional outcomes: Low Density Lipoprotein (LDL), High Density Lipoprotein (HDL), triglycerides (TG), total serum cholesterol (TC). Data will be extracted by 2 researchers independently, risk of bias of the meta-analysis will be evaluated based on the Cochrane Handbook for Systematic Reviews (SR) of Interventions. All data analysis will be conducted by data statistics software Review Manager V.5.3. and Stata V.12.0. Results: The results of this study will systematically evaluate the effectiveness and safety of Multiple dietary fiber diet interventions in the treatment of gestational hyperinsulinism. Conclusion: The SR of this study will summarize the current published evidence of Multiple dietary fiber for the treatment of gestational hyperinsulinism, which can further guide the promotion and application of it. Ethics and dissemination: This study is a SR, the outcomes are based on the published evidence, so examination and agreement by the ethics committee are not required in this study. We intend to publish the study results in a journal or conference presentations. Open Science Fra network (OSF) registration number: August 19, 2020. osf.io/tbc7z. (https://osf.io/tbc7z)