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      Effects of probiotics on glycemic control and intestinal dominant flora in patients with type 2 diabetes mellitus : A protocol for systematic review and meta-analysis

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          Abstract

          Background:

          With the rapid development of modern society, people's dietary structure has been changing accordingly. Diets high in salt, fat, and sugar have led to an increase in the incidence of diabetes year by year, posing a great threat to human health. More than 90% of diabetic patients have type 2 diabetes mellitus (T2DM). It is currently believed that the onset of T2DM is mainly related to factors such as genetics, insulin resistance, impaired insulin cell function, and obesity. The main mechanisms are as follows:

          • 1.

            It affects the intestinal intake of single-chain fatty acid (SCFAs). The decrease of SCFAs leads to the decrease of the number of islet cells and the decrease of insulin sensitivity, which in turn leads to insulin resistance (IR).

          • 2.

            Intestinal barrier function is inhibited, which leads to intestinal nonspecific inflammation. Then, it leads to changes in the structure and function of intestinal endothelial cells and affects the transport of insulin, which leads to IR.

          • 3.

            Intestinal flora participates in bile acid metabolism and liver circulation, and affects the metabolism of carbohydrates and lipids. Imbalance of intestinal flora leads to disorders of carbohydrate and lipid metabolism.

          • 4.

            Intestinal flora can reduce oxidative stress and improve islet cell function and insulin metabolism. Imbalance of intestinal flora can lead to impaired islet cell function and insulin resistance.

          • 5.

            Normal intestinal flora can increase the content of YY peptide and correct the abnormal nerve conduction in hypothalamic feeding center.

          The dominant flora of normal intestinal tract is mainly anaerobic bacteria which are beneficial to the human body. Under certain conditions, when intestinal flora is maladjusted, harmful bacteria and opportunistic bacteria become the dominant intestinal bacteria, resulting in metabolic disorders. Ingestion of probiotics can correct the imbalance of intestinal flora, and then, have a therapeutic effect on T2DM. Therefore, we designed this study to evaluate the effects of probiotics on blood glucose control and intestinal dominant flora in patients with T2DM.

          Methods:

          The retrieval period of meta-analysis literature is set from January 1, 1990 to September 2020. We will mainly search five English electronic databases, including Cochrane Library, Pubmed, Excerpt Medical Database (EMBASE), Science Direct and Web of Science, and search the following four Chinese databases: China Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), China Science Journal Database (VIP), Wanfang Database, and so on. At the same time, the two reviewers will independently conduct research selection, data extraction and deviation risk assessment, and use Review Manager 5.3 software provided by the Cochrane Collaboration for meta-analysis and heterogeneity assessment.

          Results:

          This study will demonstrate an evidence-based review of probiotics on glycemic control and intestinal dominant flora in patients with type 2 diabetes mellitus.

          Conclusion:

          This study can be used to evaluate the efficacy and safety of probiotics on glycemic control and intestinal dominant flora in patients with T2DM.

          Registration number:

          is INPLASY202090104.

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          Most cited references32

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          WITHDRAWN: Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: results from the International Diabetes Federation Diabetes Atlas, 9th edition

          To provide global estimates of diabetes prevalence for 2019 and projections for 2030 and 2045.
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            GRADE guidelines: 3. Rating the quality of evidence.

            This article introduces the approach of GRADE to rating quality of evidence. GRADE specifies four categories-high, moderate, low, and very low-that are applied to a body of evidence, not to individual studies. In the context of a systematic review, quality reflects our confidence that the estimates of the effect are correct. In the context of recommendations, quality reflects our confidence that the effect estimates are adequate to support a particular recommendation. Randomized trials begin as high-quality evidence, observational studies as low quality. "Quality" as used in GRADE means more than risk of bias and so may also be compromised by imprecision, inconsistency, indirectness of study results, and publication bias. In addition, several factors can increase our confidence in an estimate of effect. GRADE provides a systematic approach for considering and reporting each of these factors. GRADE separates the process of assessing quality of evidence from the process of making recommendations. Judgments about the strength of a recommendation depend on more than just the quality of evidence. Copyright © 2011 Elsevier Inc. All rights reserved.
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              Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015: elaboration and explanation.

              Protocols of systematic reviews and meta-analyses allow for planning and documentation of review methods, act as a guard against arbitrary decision making during review conduct, enable readers to assess for the presence of selective reporting against completed reviews, and, when made publicly available, reduce duplication of efforts and potentially prompt collaboration. Evidence documenting the existence of selective reporting and excessive duplication of reviews on the same or similar topics is accumulating and many calls have been made in support of the documentation and public availability of review protocols. Several efforts have emerged in recent years to rectify these problems, including development of an international register for prospective reviews (PROSPERO) and launch of the first open access journal dedicated to the exclusive publication of systematic review products, including protocols (BioMed Central's Systematic Reviews). Furthering these efforts and building on the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines, an international group of experts has created a guideline to improve the transparency, accuracy, completeness, and frequency of documented systematic review and meta-analysis protocols--PRISMA-P (for protocols) 2015. The PRISMA-P checklist contains 17 items considered to be essential and minimum components of a systematic review or meta-analysis protocol.This PRISMA-P 2015 Explanation and Elaboration paper provides readers with a full understanding of and evidence about the necessity of each item as well as a model example from an existing published protocol. This paper should be read together with the PRISMA-P 2015 statement. Systematic review authors and assessors are strongly encouraged to make use of PRISMA-P when drafting and appraising review protocols. © BMJ Publishing Group Ltd 2014.
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                Author and article information

                Journal
                Medicine (Baltimore)
                Medicine (Baltimore)
                MEDI
                Medicine
                Lippincott Williams & Wilkins (Hagerstown, MD )
                0025-7974
                1536-5964
                13 November 2020
                13 November 2020
                : 99
                : 46
                : e23039
                Affiliations
                [a ]College of Basic Medicine
                [b ]College of Clinical Medicine
                [c ]College of International Education, Chengdu University of Traditional Chinese Medicine, Chengdu, P.R. China.
                Author notes
                []Correspondence: Yongxiang Gao, College of International Education of Chengdu University of Traditional Chinese Medicine, No. 37 Shi-er-qiao Road, Chengdu 610075 (e-mail: gaoyxcdtcm@ 123456126.com ); Lisha He, College of Basic Medicine of Chengdu University of Traditional Chinese Medicine, No. 37 Shi-er-qiao Road, Chengdu 611137, Sichuan Province, P.R. China (e-mail: jqhelisha@ 123456163.com ).
                Article
                MD-D-20-09675 23039
                10.1097/MD.0000000000023039
                7668435
                33181668
                3f7a2b7b-74ad-4d0b-9b6d-355f8d58b4a3
                Copyright © 2020 the Author(s). Published by Wolters Kluwer Health, Inc.

                This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. http://creativecommons.org/licenses/by/4.0

                History
                : 2 October 2020
                : 7 October 2020
                Categories
                4300
                Research Article
                Study Protocol Systematic Review
                Custom metadata
                TRUE

                intestinal dominant flora,probiotics,t2dm
                intestinal dominant flora, probiotics, t2dm

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