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: Diabetic patients with proven cardiovascular disease will be treated with a 10 mg dose of ampogliflozin at a six-month interval in addition to their previous treatm
Sponsors
Zanjan University of Medical Sciences
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: type2 diabetes age more than 40 stablished cardiovascular disease with angiography HbA1c between 7 to 9
Exclusion criteria
Exclusion criteria: heart failure (EF<40 %) history of myocardial infarction or un stable angina during 6 month ago Recent anemia severe kidney disease(GFR<30)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of illness. Timepoint: six month. Method of measurement: questionnaire.;Drug history. Timepoint: six month. Method of measurement: questionnaire.;Empagliflozine. Timepoint: period six month. Method of measurement: questionnaire.;Erythropoetin level. Timepoint: six month. Method of measurement: ELAISA.;Spot albumin to Cr. Timepoint: six month. Method of measurement: dip stick.;Serum hemoglobin levels before and after treatment. Timepoint: six month. Method of measurement: immunoichemilosent.;Echocardiography. Timepoint: six month. Method of measurement: echocardiography device. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluation of changes in serum erythropoietin levels before and after the use of impagliflozin compared with placebo in diabetic patients with stable cardiovascular disease2. Evaluation of the relationship between changes in serum erythropoietin level and changes in hematopoietic indexes before and after the use of ampogliflozin compared with placebo in diabetic patients with stable cardiovascular disease3. Evaluation of the relationship between changes in serum erythropoietin level and Alb / cr changes before and after the use of ampoglifluosine compared with placebo in diabetic patients with stable cardiovascular disease4. Evaluation of the relationship between changes in serum erythropoietin level and the magnitude of changes in echocardiographic indices before and after the use of ampogliflozin compared with placebo in diabetic patients with stable cardiovascular disease5. Evaluation of the relationship between changes in FBS, HbA1c and serum levels of erythropoietin before and after the use of ampogliflosin compared with placebo in diabetic patients with stable cardiovascular disease6. Evaluation of fasting serum insulin level in patients taking oral hypoglycemic drugs before and after impagliflozin compared with placebo in diabetic patients with stable cardiovascular disease7. Evaluation of the relationship between changes in echocardiographic indices with Alb / cr before and after the use of ampoglifluosine compared with placebo in diabetic patients with stable cardiovascular disease. Timepoint: At a six-month interval after the administration of empagliflosine and placebo. Method of measurement: ELISA KIT. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr Reyhaneh Mahmoodian
Zanjan University of Medical Sciences
Outcome results
None listed