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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
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BMC Cardiovascular Disorders

ISSN: 1471-2261

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