Pancreatic stone protein as a novel biomarker of microvascular complications in type II diabetes mellitus: A systematic review and meta-analysis

A BSTRACT Objectives: Pancreatic stone protein (PSP) has been identified as an indicator of systemic stress and is elevated in individuals diagnosed with type 2 diabetes mellitus (T2DM), potentially serving as a prognostic marker for both the onset and progression of the disease. Materials and Methods: This study was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analysis 2020 guidelines. Articles were sourced from MEDLINE, ProQuest, Science Direct, Google Scholar, and Cochrane Library electronic databases. Studies included are all observational studies examining PSP/Reg1α serum levels in patients with T2DM. The quality of the study was evaluated using the Newcastle–Ottawa Scale, as well as Review Manager 5.4 to perform the meta-analysis. Results: Seven studies met the criteria for inclusion. Pooled analysis revealed significant differences in PSP values between T2DM individuals and healthy controls (standardized mean difference [SMD] = 2.14, 95% confidence interval CI: 1.05–1.92, P < 0.00001). Further subgroup analysis showed PSP was substantially higher in T2DM with complications (SMD = −1.57, 95% CI: −2.12 to −1.02, P < 0.00001) compared to T2DM without complications (SMD = −1.39, 95% CI: −2.17 to − 0.61) and newly diagnosed T2DM (SMD = −1.85, 95% CI: −2.96 to −0.74). Grading of Recommendations, Assessment, Development, and Evaluations demonstrated moderate quality of evidence. Conclusion: Our analysis revealed a progressive elevation in PSP values concomitant with the worsening T2DM disease state across the entire spectrum. PSP exhibits promising potential as a biomarker for predicting both disease initiation and subsequent clinical course.