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Table 4 The detailed descriptions of selected outcomes

From: Study rationale and design of a study of EMPAgliflozin’s effects in patients with type 2 diabetes mellitus and Coronary ARtery disease: the EMPA-CARD randomized controlled trial

Outcome Method of measurement Mechanism Time of measurement
Changes in plasma IL-6 and 1-beta levels Plasma IL-6 and IL-1b Elisa kits Key cytokines in development and maintenance of inflammation Week 0 and 26
Changes in oxidative stress (Lymphocytic ROS, plasma MDA, Carbonyl, T-AOC, GSHr, CAT activity and SOD enzyme activity levels) Flow cytometry (DCFDA as dye)a, spectrophotometry, colorimetric and FRAP assays ROS, MDA and carbonyl increase in inflammation and causes cell damage
GSHr, AOC, CAT activity and SOD activity increase in inflammation and reduce oxidative stress
Week 0 and 26
Changes in serum hs-CRP level Turbidimetric assay Circulating concentrations rise in response to inflammation Week 0 and 26
Changes in platelet functionb Flow cytometry (MFI of CD62-P expression on platelet surface) Platelet activity increases in DM and inflammation causing platelet dysfunction Week 0 and 26
Changes in HbA1c, FBS and Basal Insulin level Enzymatic assay Indicate the glycemic status which is reduce with anti-glycemic drugs Week 0 and 26
Changes in HOMA-IRc fasting insulin (mU/mL) × fasting glucose (mg/dL)/405 A method used to quantify insulin resistance which increases in DM and insulin resistance conditions Week 0 and 26
Changes in serum hs-troponin I, BNP and NT-proBNP levels Chemiluminescence assay Specific cardiac biomarkers increase in cardiomyocyte damage and tension Week 0 and 26
Changes in blood Hb, Hct and serum erythropoietin CBC and serum erythropoietin Elisa kit Reflects the hematopoietic status Week 0 and 26
Changes in urine micro-albuminuria and albumin to creatinine ratio Photometry and enzymatic assays Reflects the renal and glomerular function. May increase in in DM as a microvascular adverse event Week 0 and 26
Changes in lipid profile (serum TG, cholesterol, HDL,LDL cholesterols) Enzymatic assay Lipid disorders increase in DM which raises the cardiovascular complications that may decrease with empagliflozin treatment Week 0 and 26
Changes in echocardiography parameters 2D trans-thoracic Echocardiography Reflects left ventricular systolic and diastolic and right ventricular function Week 0 and 26
Changes in electrocardiographic parameters Electrocardiography Reflects the electrophysiological activity of the heart Week 0 and 26
  1. IL-6 interleukin 6, IL-1b interleukin 1-beta, ROS reactive oxygen species, MDA malondialdehyde, T-AOC total antioxidant capacity, GSHr reduced glutathione, CAT catalase, SOD superoxide dismutase, DCFDA dichlorofluorescin diacetate, FRAP fluorescence recovery after photobleaching, hs-CRP high sensitive C-reactive protein, MFI mean fluorescent index, DM diabetes mellitus, HbA1c glycated hemoglobin, FBS fasting blood glucose, HOMA-IR homeostatic model assessment for insulin resistance, hs-Troponin I high sensitive troponin I, BNP brain natriuretic peptide, NT-proBNP N-terminal pro-brain natriuretic peptide, Hb hemoglobin, Hct hematocrit, CBC complete blood count, TG triglyceride, HDL high density lipoprotein, LDL low density lipoprotein cholesterol
  2. aTo assess the changes in ROS production, peripheral blood mononuclear cells (PBMC) will be separated from fresh whole blood and lymphocytes will be gated through sample acquisition in flow cytometric analysis
  3. bTo minimize the time interval between sample drawing and sample acquisition (less than 90 min) and any further manipulation which may result in unwanted platelet activation, the activation test was set up on whole blood via Thrombin Receptor Activator Peptide 6 (TRAP-6). The platelet concentrated area will be gated during sample acquisition and the MFI in histogram plot will be measured by Human CD62-P FITC antibody
  4. cPatients who are under treatment with insulin in any form will be excluded from the analysis