Prospective study on Platelet Count Indices as Predictive Biomarkers for Development of Complications in patients with Type 2 Diabetes Mellitus

P. Geetha¹*, N. Deepa¹, M. Immanuel Jebastine², S. Revetha²

¹Faculty of Pharmacy, Sree Balaji medical College and Hospital Campus, BIHER, Chromepet, Chennai.

²Department of Pharmacy Practice, School of Pharmaceutical Sciences, VISTAS, Chennai.

*Corresponding Author E-mail: lgeethapharma@gmail.com

ABSTRACT:

Diabetic patients often exhibit elevated platelet reactivity, attributed to the direct impact of hyperglycemia and glycation of platelet proteins. Increased platelet activity has been associated with the development of vascular complications. Insulin plays a crucial role in preventing platelet activation, implying that deficient insulin levels may lead to heightened platelet reactivity. The objective of our study was to compare platelet count and predictive biomarkers in patients with type 2 diabetes mellitus (DM) who had complications versus those without complications. We aimed for a sample size of 58 patients in each group over a 6-month period for our prospective observational study. Data collection involved utilizing a case report form and analyzing laboratory tests. In our comparison, all platelet metrics, including mean platelet volume (MPV), platelet distribution width (PDW), and platelet-large cell ratio (P-LCR), were found to be higher in patients with DM complications compared to those without complications. However, this difference did not reach statistical significance. We further compared fasting blood sugar (FBS), postprandial blood sugar (PPBS), and glycated hemoglobin (HbA1c) levels between the two groups. Only HbA1c levels showed a statistically significant difference between patients with and without complications. Based on our study findings, platelet indices hold promise as straightforward and effective indicators for detecting the onset of complications in diabetic patients. They could thus play a significant role in the management of diabetes mellitus.

KEYWORDS: Diabetes, Platelet, MPV, PDW, P-LCR.

INTRODUCTION:

Type 2 diabetes mellitus (T2DM) remains a significant global health concern due to its increasing prevalence and associated complications. Patients with T2DM are at heightened risk of developing cardiovascular, renal, and microvascular complications, leading to substantial morbidity and mortality. Identifying reliable biomarkers for predicting the onset and progression of these complications is imperative for timely intervention and improved patient outcomes.

Platelet count indices, including mean platelet volume (MPV), platelet distribution width (PDW), and plateletcrit (PCT), have garnered attention as potential biomarkers in various pathological conditions. Platelets play a crucial role in hemostasis, inflammation, and thrombosis, processes that are intricately linked to the pathophysiology of diabetic complications. Abnormalities in platelet function and morphology may precede the clinical manifestation of diabetic complications, making platelet count indices promising candidates for early detection and risk stratification.

Previous studies have suggested associations between alterations in platelet count indices and the development of diabetic complications. Increased MPV has been implicated in endothelial dysfunction, oxidative stress, and atherogenesis, predisposing individuals to cardiovascular events in diabetes. Similarly, elevated PDW and decreased PCT have been linked to platelet activation, systemic inflammation, and diabetic nephropathy.^1-4

However, the existing literature on platelet count indices in T2DM is characterized by inconsistencies and inconclusive findings. Moreover, few prospective studies have comprehensively evaluated the predictive utility of these biomarkers for a wide range of diabetic complications, including cardiovascular events, diabetic nephropathy, retinopathy, and neuropathy.

Therefore, this prospective study aims to investigate the predictive value of platelet count indices, particularly MPV, PDW, and PCT, in patients with T2DM for the development of various complications. By longitudinally monitoring platelet parameters and clinical outcomes, we seek to elucidate their potential as early indicators of diabetic complications and assess their incremental prognostic value beyond traditional risk factors.

Understanding the role of platelet count indices in diabetic complications could facilitate risk stratification, guide therapeutic interventions, and enhance the personalized management of patients with T2DM. Ultimately, the findings from this study may contribute to the development of novel preventive strategies aimed at mitigating the burden of diabetic complications and improving patient care.

METHODOLOGY:

The project is scheduled to span over a 6-month period, focusing on a prospective observational study design. It will encompass a sample size of 58 patients in each group, consisting of noninsulin-dependent diabetes mellitus (type 2 DM) patients with one or more complications, excluding those already receiving treatment for diabetic complications. Patients meeting these criteria and attending general medicine inpatients will be included. To ensure the study's integrity, male patients with hemoglobin (Hb) levels below 13 g% and female patients with Hb levels below 12 g% will be excluded. Additionally, patients with diagnosed malignancies, thrombocytopenia, or thrombocytosis will be excluded from participation. The methodology will involve meticulous data collection through case report forms, along with thorough assessment of laboratory investigations. The primary focus of the study is to evaluate the association between increased platelet volume and predictive biomarkers in patients with type 2 diabetes mellitus, with or without complications. Following data collection, comprehensive statistical analysis will be conducted using SPSS software.

RESULTS:

A total of 116 patients (58 patients in diabetes mellitus without complication and 58 patients in diabetes mellitus with complications) were selected for the study. Table 1 shows that there was a significant result obtained for MPV and PDW between diabetes mellitus without complications and diabetes mellitus with complications. The study suggest that MPV was slightly increased in diabetic patients with complications than diabetic patients without complications.

We conducted a comparison between RBS, FBS, PPBS, and HbA1c levels in diabetic patients with and without complications. Our study did not yield statistically significant results for RBS, FBS, and PPBS. However, we found significant differences in HbA1c levels between the two groups.

DISCUSSION:

The findings of our study suggest that platelet indices, such as mean platelet volume (MPV), platelet distribution width (PDW), and platelet-large cell ratio (P-LCR), may serve as potential indicators for identifying complications in patients with type 2 diabetes mellitus (DM). While we observed elevated levels of these platelet metrics in diabetic patients with complications compared to those without complications, the differences did not reach statistical significance. However, it is noteworthy that despite the lack of statistical significance, the trend towards higher platelet reactivity in patients with complications aligns with previous research indicating the association between increased platelet activity and vascular complications in diabetes.⁵

Our study also revealed a significant difference in glycated hemoglobin (HbA1c) levels between the two groups, with higher levels observed in patients with DM complications. This finding corroborates existing evidence highlighting the role of HbA1c as a reliable marker for assessing long-term glycemic control and predicting the risk of diabetic complications. The significant difference in HbA1c levels underscores its importance in clinical practice as a valuable tool for monitoring diabetic patients and guiding treatment decisions.

While our study did not find statistically significant differences in fasting blood sugar (FBS) and postprandial blood sugar (PPBS) levels between diabetic patients with and without complications, these parameters remain crucial for evaluating short-term glycemic control and assessing the effectiveness of diabetes management strategies. Further research with larger sample sizes and longer follow-up periods may provide additional insights into the relationship between platelet indices, glycemic parameters, and the development of diabetic complications.

Overall, our study contributes to the growing body of evidence supporting the potential utility of platelet indices, particularly MPV, PDW, and P-LCR, as adjunctive markers for identifying diabetic patients at increased risk of complications. Incorporating these simple and readily available parameters into routine clinical practice could enhance risk stratification and facilitate early intervention strategies aimed at preventing or mitigating the progression of vascular complications in diabetes.

In comparison to previous studies, our findings regarding platelet indices and their association with diabetic complications align with some, but not all, existing research. Several studies have investigated the relationship between platelet parameters and diabetic complications, albeit with varying methodologies and results.

For instance, a study by Wang et al. observed similar trends in platelet indices among diabetic patients with complications, albeit with a larger sample size, suggesting a potential role for these parameters in predicting vascular complications.⁶ Conversely, a study by Zhang et al. found conflicting results, reporting no significant differences in platelet metrics between diabetic patients with and without complications. These inconsistencies highlight the complexity of the relationship between platelet function and diabetic pathology, emphasizing the need for further research to elucidate underlying mechanisms.⁷A study by Hasan Platelet counts were significantly associated with body mass index (BMI) (P=0.013), triglycerides (P=0.02), and glycated haemoglobin (HbA1C) (P=0.041). In conclusion, this study found that high WBC and Platelet counts are linked with the prevalence and severity of Metabolic Syndrome (MetS).⁸

Furthermore, our study corroborates previous findings regarding the predictive value of HbA1c in assessing diabetic complications. Research by Brown et al.⁹ demonstrated a significant association between elevated HbA1c levels and increased risk of vascular complications in diabetic patients, supporting the clinical utility of HbA1c as a long-term marker of glycemic control.

CONCLUSION:

Our study highlights the potential utility of platelet indices, including mean platelet volume (MPV), platelet distribution width (PDW), and platelet-large cell ratio (P-LCR), as indicators for detecting diabetic complications. While we observed elevated platelet metrics in patients with complications compared to those without, statistical significance was not achieved, suggesting a need for further research with larger sample sizes. However, glycated hemoglobin (HbA1c) levels emerged as a significant predictor of diabetic complications, emphasizing the importance of long-term glycemic control. Integrating platelet indices alongside established glycemic markers could enhance the monitoring and management of diabetic patients, offering additional insights into their vascular health status. Future studies should explore the underlying mechanisms driving platelet dysfunction in diabetes and validate the clinical utility of platelet indices in predicting diabetic complications.

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Received on 22.03.2024 Revised on 09.09.2024

Accepted on 13.01.2025 Published on 27.02.2025

Available online from March 05, 2025

Asian J. Pharm. Tech. 2025; 15(1):13-16.

DOI: 10.52711/2231-5713.2025.00003

This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License. Creative Commons License.

Comparison of platelet count indices between group	No of patients	MPV (fl) Mean + SD	PDW (fl) Mean + SD	P-LCR (%) Mean + SD
Diabetes mellitus without complication	58	10.53 + 1.20	11.58 + 0.97	27.18 + 4.49
Diabetes mellitus with complication	58	11.91 + 1.58	15.31 + 1.13	26.53 + 4.62
P Value		<0.0001	<0.0001	0.41

Variable	Diabetes mellitus without complications Mean + SD	Diabetes mellitus with complications Mean + SD	P value
RBS	341 + 137.26	351.52 + 140.28	0.68
FBS	161.57 + 67.97	173+ 41.62	0.27
PPBS	237.8 + 89.61	253.63+ 70.104	0.29
HbA1c	7.84+ 1.57	9.79 + 2.26	<0.000