The Changes That Occur in the Immune System During Immune Activation in Patients With Prediabetes From All Ethnicities, Aged 25-45 Years: Protocol for a Systematic Review and Meta-analysis

BACKGROUND: Prediabetes is an asymptomatic, intermediate state between normoglycemia and the onset of type 2 diabetes mellitus. Recent reports indicate that during prediabetes, there are subclinical changes to immune cells and inflammatory markers. Therefore, this systematic review will provide a synthesis of the available data on the changes in the concentration of immune cells and selective inflammatory markers. It will also give evidence of a demographic impact on changes or complications in the prediabetes state. OBJECTIVE: The objectives of this study are to create a protocol that will be used to analyze the collected data of previously published research based on immune cells such as neutrophils, lymphocytes, monocytes, eosinophils, and basophils, as well as inflammatory markers such as C-reactive protein, tumor necrosis factor-alpha, interleukin-6, P-selectin, cluster of differentiation 40 ligand, and fibrinogen. Additionally, an impact of demographics will be determined using the previously published data collected. METHODS: This protocol was prepared through adhering to the PRISMA (Preferred Reporting Items for Systemic Reviews and Meta-Analysis) 2015 guidelines for reporting protocols. Published clinical studies that involve observational (cross-sectional, comparative cross-sectional, case-control, or cohort) study designs that include normal or nondiabetic and prediabetes reports will be used in this systematic review and meta-analysis. This will be accomplished by using clinical Medical Subject Headings to search on MEDLINE, Cochrane library, and African Journal Online. Reviewers (NCM, AMS, and AK) will screen all the results and select the studies that meet the eligibility criteria. Downs and Black Checklist will be used to check the risk of bias, and then a Review Manager v5.4 forest plot will be used for meta-analysis. Additionally, the forest plot will also be used for sensitivity analysis. The strength of evidence will then be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Since July 5, 2020, there are no participants recruited. Publicly available data will be used in the review and will be collected after this protocol publication. No ethics approval is required as no subjects will be used, and analysis will be based on reported data. Authors will be contacted if there was a misunderstanding related to reading their reported data. CONCLUSIONS: The findings will clarify changes that might be observed in a study of interest based in the eThekwini district in South Africa. TRIAL REGISTRATION: International Prospective Registry of Systematic Reviews (PROSPERO) CRD42020184828; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=184828 INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/31619