Study the changes in anti-inflammatory and anti-oxidative biomarkers in Type 2 diabetes patients on Metformin treatment with combination drugs of Metformin+Vildagliptin and Metformin+Glimipride

The present study involves three groups: 1) Metformin 2) Metformin along with Vildagliptin 3) Metformin along with glimipiride. The drug treatment will be prescribed depending on the condition of patients by the physician as in case of initiation of treatment, it is usual practice to prescribe metformin, however, if it fails to achieve the hypoglycemic control in around 3 months, then combination therapy of Metformin+Vildagliptin and Metformin+glimipride (patients with GI complications) will be prescribed for the patients. In the present study, at baseline level 75 patients will be divided in to three groups of 25 patients each who are confirmed with T2DM by fasting blood sugar and glycated hemoglobin (HbA1c). Other than this, cholesterol, triglyceride, HDL, LDL amd VLDL will be analysed. In the patients, this will be followed by estimation of status of anti-oxidative biomarkers, superoxide dismutase in plasma. Followed by this, the level of anti-inflammatory biomarkers will be assessed including CRP, Nuclear factor-kappa B (NF-kB), AGE, RAGE and interleukin-6 (IL-6) in T2DM patients’ plasma. The sample will be collected from the patients who will visit the outpatient department of the hospital for taking the prescription from the physicians and sample will be collected at the same time for performing the different basic investigations and also, after one month of different treatments to see the beneficial effects of the drugs, hence, in total two time blood sample will be collected for one time follow up after one month post treatment. No charges will be taken from the patients as the fund for performing the investigations of the study is already approved by the LRAC, MRU, KCGMC, Karnal (budget details attached), rather it is beneficial for the patients to know the status of biomarkers and getting better treatment or doses regulation based on the status of biomarkers by the physician. The patients’ blood samples of five mL will be collected for the investigations required for a diabetic patient which will be utilized for the estimation of different anti-oxidative and anti-inflammatory biomarkers, therefore, no extra blood sample will be taken to minimize the harm to the patients. The number of patients visiting to the OPD of KCGMC is enough to meet the sample size in one year for the present study as observed by the PI. Thereafter, these confirmed patients will be provided treatment: A) Metformin B) Metformin + Vildagliptin C) Metformin + glimipiride. Different drug treatment will be prescribed by the clinicians and only observations will be recorded by the investigators. The tests will be performed by the staff of MRU, KCGMC, Karnal in the laboratory. The patients’ blood samples will be collected after one month of treatment for the estimation of different antioxidative biomarkers including superoxide dismutase level. Followed by this, different anti-inflammatory biomarkers will be estimated including CRP, Nuclear factor-kappa B (NF-kB), AGE, RAGE, and interleukin-6 (IL-6) in plasma. Other than this, fasting blood sugar and glycated hemoglobin (HbA1c), cholesterol, triglyceride, HDL, LDL and VLDL will be analysed.