Potential Molecular level Impact of Cresvin beta on Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial

Abstract

Background: Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder with an increasing prevalence rate over the past few decades. Despite the availability of medications to prevent and reduce disease severity, T2DM prevalence and incidence continue to rise annually. Understanding genetic heritage's impact on therapeutic responses is improving, with pharmacogenetics being used to better comprehend the therapeutic variability of T2DM. This study aims to compare the effects of metformin and Cresvin beta capsules containing Pterocarpus marsupium, Withania somnifera, Salacia reticulata, Gymnema Sylvestre, Curcuma longa, Vitis vinifera and Piper nigrum (Black pepper extract) on diabetic and immune-related gene expression in T2DM patients. Methods: Sixty patients were divided into two groups: metformintreated (group A, n=30) and Cresvin beta -treated (group B, n=30). Anthropometric, biochemical, and hematological parameters were measured at baseline and after 3 months of treatment. Gene expression levels were analyzed using quantitative real-time polymerase chain from DNA extracted from whole blood samples. Results: After 3 months, metformin significantly reduced fasting blood sugar (FBS), postprandial blood sugar (PPBS), and HbA1c levels (p<0.001). Cresvin beta also significantly reduced FBS (p<0.01), PPBS (p<0.001), and HbA1c (p<0.001). Gene expression analysis showed significant changes in SIRT1, AKT, SLC2A4, IL-6, and TNF-α in both groups. Conclusion: The study demonstrated that Cresvin beta reduced glycemic levels and improved SIRT1, Pi3k, Akt, and SLC2A4 gene expression while decreasing IL-6 and TNF-α cytokine gene expression in T2DM patients.