Satta Ersilia, Strollo Felice, Borgia Luisa, Guarino Giuseppina, Romano Carmine, Masarone Mario, Marfella Raffaele, Gentile Sandro
Nefrocenter Research Network, Cava de´ Tirreni, Italy.
Department of Endocrinology and Diabetes, IRCCS San Raffaele Pisana, Rome, Italy.
Diabetes Ther. 2025 Jun;16(6):1107-1124. doi: 10.1007/s13300-025-01731-w. Epub 2025 Apr 3.
Patients with diabetes mellitus (DM) are at risk of developing diabetic nephropathy (DN), a condition whose onset and progression are linked to increased morbidity and mortality. Therefore, early recognition is crucial. Presently, this relies on the albumin excretion rate (AER) and glomerular filtration rate (GFR). Nevertheless, DN eventually affects patients with normal AER and GFR. Thus, further easy-to-handle biomarkers of DN onset/worsening are needed. Liver-type fatty acid-binding protein (L-FABP) has been associated with renal damage and could help predict/diagnose DN. We performed a literature selection to evaluate the performance of urinary excretion of such biomarker (urinary-L-FABP:uL-FABP) in predicting/diagnosing DN and its progression in diabetes. We evaluated 635 publications, 21 of which were included. Of these, 14 have cross-sectional design/arms and ten longitudinal design/arms. Cross-sectional studies showed uL-FABP to correlate with DN onset and severity in type-1 DM and type-2 DM, besides being higher than in healthy controls in the case of normoalbuminuria. Longitudinal studies showed baseline uL-FABP to predict DN onset in normoalbuminuric patients with T1DM and DN progression independently of diabetes type. The results suggest that uL-FABP is a marker of tubular damage detectable before increased albumin excretion and can represent the earliest sign of DN. Indeed, it discloses its onset and often predicts its severity in T2DM and patients with T1DM. Currently, uL-FABP can be routinely assessed and, being available as a point-of-care fast-test kit, may also become an easy-to-handle diagnostic tool for outpatients. In conclusion, uL-FABP represents a user-friendly biomarker of DN and can even predict DN progression in T2DM and T1DM over time.
糖尿病（DM）患者有患糖尿病肾病（DN）的风险，这种疾病的发生和进展与发病率和死亡率的增加有关。因此，早期识别至关重要。目前，这依赖于白蛋白排泄率（AER）和肾小球滤过率（GFR）。然而，DN最终会影响AER和GFR正常的患者。因此，需要进一步易于操作的DN发病/恶化生物标志物。肝型脂肪酸结合蛋白（L-FABP）与肾损伤有关，可能有助于预测/诊断DN。我们进行了文献筛选，以评估这种生物标志物的尿排泄（尿L-FABP：uL-FABP）在预测/诊断DN及其在糖尿病中的进展方面的性能。我们评估了635篇出版物，其中21篇被纳入。其中，14篇有横断面设计/研究组，10篇有纵向设计/研究组。横断面研究表明，uL-FABP与1型糖尿病和2型糖尿病中DN的发生和严重程度相关，此外，在正常白蛋白尿的情况下，其水平高于健康对照组。纵向研究表明，基线uL-FABP可独立于糖尿病类型预测正常白蛋白尿的1型糖尿病患者的DN发病和DN进展。结果表明，uL-FABP是在白蛋白排泄增加之前可检测到的肾小管损伤标志物，并且可以代表DN的最早迹象。事实上，它揭示了DN的发病，并常常预测其在2型糖尿病和1型糖尿病患者中的严重程度。目前，uL-FABP可以常规评估，并且作为即时检测快速测试试剂盒可用，也可能成为门诊患者易于操作的诊断工具。总之，uL-FABP是一种用户友好的DN生物标志物，甚至可以随时间预测2型糖尿病和1型糖尿病中的DN进展。
