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CKD was diagnosed based on the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines. Exclusion criteria included participation in other trials, acute kidney injury, end-stage kidney disease undergoing renal replacement therapy, pregnancy, active infections, gastrointestinal or pancreatic inflammation, history of gastrointestinal or pancreatic resections, cancer and mental disorders.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Serum REG I\u03b1 was significantly higher in the CKD group (125.54 (60.28\u2013303.39)\u2009ng\/mL) compared with those in the non-CKD group (24.62 (14.09\u201337.32)\u2009ng\/mL, p&lt;0.001). Positive correlations were observed between serum REG I\u03b1 and serum creatinine, cystatin C (Cys-C), and kidney injury molecule 1 (KIM-1), while a negative correlation was identified with eGFR. After adjusting for sex, diabetes, hypertension and fasting blood glucose, the multivariate regression analysis demonstrated a significant association between serum REG I\u03b1 and eGFR (OR=1.737 (1.263\u20132.388), p=0.001). Furthermore, serum REG I\u03b1 levels increased progressively with declining kidney function categorised by eGFR (p&lt;0.001). In CKD screening, serum REG I\u03b1 demonstrated strong diagnostic performance, with an area under the receiver operating characteristic curves (AUC) of 0.860 (0.813\u20130.899), providing a sensitivity of 71.63%, a specificity of 86.89%, a positive predictive value of 94.30% and a negative predictive value of 46.85%. Additionally, serum REG I\u03b1 exhibited an AUC of 0.769 (0.712\u20130.819) for identifying high- and very-high-risk CKD based on KDIGO risk stratification. Its sensitivity significantly outperformed serum Cys-C and KIM-1 (82.80% vs 75.16% and 36.94%, respectively).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>This study provided compelling evidence that serum REG I\u03b1 levels were notably elevated in patients with CKD and closely associated with kidney function. REG I\u03b1 may serve as a promising biomarker for CKD detection and risk stratification.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Clinical trial registration<\/jats:title>\n                    <jats:p>The study was approved by the Ethics Committee of Zhongda Hospital (approval number: 2022ZDSYLL204-P01) and conducted in compliance with the Helsinki Declaration. The clinical trial was registered under ChiCTR2300072247.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-086874","type":"journal-article","created":{"date-parts":[[2025,2,13]],"date-time":"2025-02-13T13:15:20Z","timestamp":1739452520000},"page":"e086874","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":0,"title":["Association between elevated serum REG I\u03b1 levels and eGFR decline in patients with chronic kidney disease: a cross-sectional study in eastern China"],"prefix":"10.1136","volume":"15","author":[{"given":"Nan","family":"Huang","sequence":"first","affiliation":[{"name":"Department of Endocrinology, Zhongda Hospital, School of Medicine, Southeast University, Nanjing, Jiangsu, China"},{"name":"Pancreatic Research Institute, Southeast University, Nanjing, Jiangsu, 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