Biological variation of cardiovascular biochemical markers in patients with Type 2 Diabetes Mellitus

Background: Type 2 diabetes mellitus (T2DM) is a well-established risk factor for cardiovascular diseases. We aimed to identify the biological variation of ten cardiovascular biochemical markers in T2DM patients to aid in their interpretation.

Methods: Blood samples for evaluating ten biomarkers were collected biweekly from 23 T2DM patients (10 men, 13 women) for three months. The analytical variability and variations of within-subject (CV_I) and between-subject (CV_G) levels were calculated, as well as the analytical performance specifications, reference change value (RCV), and index of individuality (II).

Results: The levels of total cholesterol (CHOL), apolipoprotein A (apoA), homocysteine (HCY), high-sensitivity troponin T (hsTnT) and N-terminal pro-brain natriuretic peptide (NT-proBNP) differed between males and females (P < 0.05). The CV_Is or CV_Gs of the biomakers were higher than those of healthy participants in Westgard online database, except for hsTnT. Triglyceride (TG), lipoprotein (a) [Lp(a)] and NT-proBNP had relatively high CV_I, CV_G and RCV, whereas CHOL, high-density lipoprotein cholesterol (HDL-C), apoA and HCY showed low variation. Moreover, the II of HDL-C, LP(a), apoA, HCY and hsTnT was <0.6 and other biochemical markers was between 0.6 and 1.4.

Conclusion: The cardiovascular biochemical markers in T2DM patients showed higher CV_I or CV_G, except for hsTnT. ApoA had the lowest CV_I and CV_G values. Population-based reference intervals should be used with caution in clinical decision-making for T2DM patients.