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