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Table 1 Trial objectives and measurement methods (measured at time = 0 and after 26 weeks of treatment)

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

Objective Definition
Primary 1. To investigate the impact of empagliflozin on plasma IL-6 level in patients with T2DM patients and coronary artery disease (established by coronary angiography)
Secondary 1. Inflammatory biomarkers
 Changes in serum hs-CRP levels
 Changes in plasma IL-1b levels
2. Oxidative stress status
 Changes in lymphocytic reactive oxygen species
 Changes in plasma levels of malondialdehyde
 Changes in plasma carbonyl levels
 Changes in plasma antioxidant capacity
 Changes in plasma reduced glutathione levels
 Changes in catalase enzyme activity
 Changes in plasma superoxide dismutase enzyme activity
3. Platelet function
 Changes in CD62-P expression on the platelet surface
4. Glycemic status
 Changes in fasting blood glucose levels
 Changes in HbA1c levels
 Changes in HOMA-IR
Additional secondary (Considered for sub-studies) 1. Changes is cardiac biomarkers
 Changes in serum hs-Troponin I levels
 Changes in serum BNP levels
 Changes in serum NT-proBNP levels
2. Echocardiographic parameters
 Changes in left ventricular systolic function
 Changes in left ventricular diastolic function
 Changes in right ventricular function
3. Hematopoietic status and renal function
 Changes in serum erythropoietin levels
 Changes in blood hematocrit levels
 Changes in hemoglobin levels
 Changes in urine micro albuminuria levels
4. Changes in lipid profile
 Changes in serum total cholesterol levels
 Changes in serum LDL cholesterol levels
 Changes in serum HDL cholesterol levels
 Changes in serum triglyceride levels
5. Electrocardiographic parameters
 Changes in PR interval duration
 Changes in QRS complex duration
 Changes in QT interval duration
 Changes in ST segment deviation
 Changes in T wave alternans
  1. IL-6 Interleukin 6, T2DM type 2 Diabetes mellitus, hs-CRP high sensitive, CRP C-reactive protein, IL-1b interleukin 1-beta, HbA1c glycated hemoglobin A1c, 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, LDL cholesterol low density lipoprotein cholesterol, HDL cholesterol high density lipoprotein cholesterol