Background: Type 2 diabetes mellitus (T2DM) characterized by insulin resistance (IR) and progressive decline in functional beta (β) cell mass partially due to increased β cell apoptosis rate. Pancreatic stone protein /regenerating protein (PSP/reg) is produced mainly by the pancreas and elevated drastically during pancreatic disorder. Beta cells are experiencing apoptosis that stimulate the expression of PSP/reg gene in surviving neighboring cells, and that PSP/reg protein is subsequently secreted from these cells which could play a role in their regeneration.

Objectives: To analyze serum levels of PSP/reg protein in T2DM patients and evaluate its correlation with the microvascular complications of the disease.

Subjects and Methods: One hundred fifty participants (64 males, 86 females; aged 40–70 years) include T2DM patients with and without microvascular complications as well as healthy controls were enrolled in this study. Biochemical parameters like random blood glucose (RBG), glycated hemoglobin (HbA1c), lipid profile, urea and creatinine (Cr) were measured. Serum values of PSP/reg protein were measured by enzyme- linked immunosorbent assay (ELISA).

Results: Serum levels of PSP/reg protein were found significantly elevated in T2DM patients with microvascular complications compared with those of controls (p<0.001) and T2DM patients without microvascular complications (p< 0.001).PSP/reg protein is correlated with type 2 DM duration (p<0.001), RBG (p<0.001), and HbA1c (p<0.001). The area under the curve (AUC) for the presence of microvascular complications was 0.973.

Conclusion: PSP/reg protein may be used as biochemical marker to predict microvascular complications of T2DM.