The Effect of Probiotic Supplementation on the Levels of Biomarkers in Diabetic Animal Model: A Research Protocol.

Introduction: Type 2 Diabetes Mellitus (T2DM) is characterised by hyperglycaemia, insulin secretion defects, or resistance. Most T2DM drugs help to improve glycaemic status, but the response varies among individuals. The modern lifestyle with unhealthy eating habits leads to gut dysbiosis. Altered gut microbiota can disrupt the host's metabolic and signaling pathways, intestinal barrier integrity, and function. Probiotics could restore a healthy microbiota in the intestine, thus improving glycaemic status. Need of the study: Probiotics may assist in re-establishing a healthy microbiota composition in the intestine. Limited studies have evaluated the supplementation of probiotics for effectively managing T2DM. Aim: To investigate the effects of probiotics on biomarker levels in type 2 diabetic male Wistar rats. Materials and Methods: This interventional case-control study will be conducted at the Centre for Toxicology and Developmental Research (CEFTE) at Sri Ramachandra Institute of Higher Education and Research, Chennai, Tamil Nadu, India. The study will involve 46 male Wistar rats divided into five groups. Diabetes will be induced by feeding the animals a High-Fat Diet (HFD) and administering a low dose of Streptozotocin (STZ) injection. Groups 1 and 2 will be on basal and HFDs, serving as negative and positive controls, respectively. Groups 3, 4 and 5 will be the intervention groups. The study duration will be four weeks and three days for diabetes induction and six weeks for intervention. Blood samples will be collected periodically to assess biomarkers, and at the end of the study, internal organs will be harvested for histopathological examination. Institutional Ethics Committee (IEC) approval has been obtained. Categorical variables will be analysed using Chi-square or Fisher's exact test, while continuous variables will be analysed using repeated measures Analysis of Variance (ANOVA). A p-value of =0.05 will be considered statistically significant, and statistical analysis will be performed using Statistical Package for Social Sciences (SPSS) version 16.0. [ABSTRACT FROM AUTHOR]