Assessment of Empagliflozin effects in coronary artery disease
- Conditions
- Condition 1: Diabetes Mellitus type 2. Condition 2: Coronary artery disease.Type 2 diabetes mellitusAtherosclerotic heart disease of native coronary arteryI125.1
- Registration Number
- IRCT20190412043247N2
- Lead Sponsor
- Zanjan University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
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
Pregnancy
Heart Failure (NYHA class 3-4), Ejection Fraction <40%
History of allergic reaction to SGLT2 inhibitors Drugs
History of SGLT2 inhibitor Drugs usage
Gastrointestinal malabsorbtion disease
History of CABG, ACS, TIA,CVA or PCI during past 3 month
History or presence of malignancy
Severe HTN
Anemia (Hb<10 g/dl)
History of heart or lung transplant
Major psychiatric disorders
History of DKA
Elevated liver enzymes >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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method