Condition 1: Diabetes Mellitus type 2. Condition 2: Coronary artery disease. Type 2 diabetes mellitus Atherosclerotic heart disease of native coronary artery
Conditions
Interventions
Intervention 1: Intervention group: The 50 patients in the intervention group will be treated with Empagliflozine 10 mg daily for 6 months (made by Abidi Pharmaceutical Company). Patients will continu
Sponsors
Zanjan University of Medical Sciences
Dr. Abidi Pharmaceutical Company
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: Age between 40-75 year-old HbA1c between 6.5 to 9 Diabetes mellitus type 2 Under fix continues anti-diabetic treatment for at least 3 month BMI less than 40 Fixed Diet and physical activity Resting heart rate between 60 to 100 b/min Use of Aspirin 80 mg/Daily for at least 3 month prior to the beginning of study Glomerular filtration rate (GFR)>45 Documented known Coronary Artery Disease
Exclusion criteria
Exclusion criteria: Pregnancy Heart Failure (NYHA class 3-4), Ejection Fraction 3 times upper normal limit Use of drugs prolonging QT interval Presence of Arrhythmia Electrolyte disorders Patients with Pace Maker Use of anti-coagulant or anti-platelet drugs for at least 3 months prior to the sampling Consumption of alcohol, Anti inflammatory drugs (except Aspirin) or Anti oxidant supplement Platelet count <100000/µl History of infection during 1 one month before sampling
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Plasma Interleukin 6. Timepoint: At the beginning of the study and the end of week 26. Method of measurement: Plasma IL-6 Elisa Kits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in oxidative stress (Changes in lymphocytic reactive oxygen species level). Timepoint: At the beginning of study and the end of week 26. Method of measurement: Flow cytometry.;Changes in oxidative stress (Changes in plasma levels of Malondialdehyde). Timepoint: At the beginning of study and the end of week 26. Method of measurement: colorimetric assay.;Changes in oxidative stress (Changes in plasma carbonyl level). Timepoint: At the beginning of study and the end of week 26. Method of measurement: colorimetric assay.;Changes in oxidative stress (Changes in total plasma antioxidant capacity). Timepoint: At the beginning of study and the end of week 26. Method of measurement: FRAP assay.;Changes in oxidative stress (Changes in plasma reduced glutathione level). Timepoint: At the beginning of study and the end of week 26. Method of measurement: colorimetric assay.;Changes in oxidative stress (Changes in plasma catalase enzyme activity). Timepoint: At the beginning of study and the end of week 26. Method of measurement: Spectrophotometery.;Changes in oxidative stress (Changes in plasma superoxide dismutase enzyme activity). Timepoint: At the beginning of study and the end of week 26. Method of measurement: Spectrophotometery.;Changes in plasma interleukin 1b. Timepoint: At the beginning of study and the end of week 26. Method of measurement: Interleukin 1b Elisa kit.;Changes in platelet function. Timepoint: At the beginning of study and the end of week 26. Method of measurement: Flow cytometric measurement (CD62-P expression on platelet surface).;Changes in serum total protein level. Timepoint: At the beginning of study and the end of week 26. Method of measurement: Spectrophotometry.;Changes in Hematopoietic status (Changes in hemoglobin). Timepoint: At the beginning of study and the end of week 26. Method of measurement: Complete blood count test.;Changes in glycemic status (Homeostatic Model Assessment of Insulin Resistance). Timepoint: At the beginning of st | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHassan Ahangar
Zanjan University of Medical Sciences
Outcome results
None listed