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This is a controlled study to measure the efficacy of using metformin or vildagliptin for type 2 diabetic patients who suffers from hypertension to reduce cardiovascular risk resulting from both diabetes and hypertension using different parameters measuring
Several studies indicated that type 2 diabetes mellitus and hypertension are associated with increased cardiovascular complications. Recently, studies suggest that metformin and vildagliptin can reduce cardiovascular complications in diabetic patients with unclear mechanisms. This work aimed to determine the effect of metformin and vildagliptin on diabetic-hypertensive patients. Patients were allocated into four groups: groupI: healthy volunteers, groupII: patients recently diagnosed with their hypertension and diabetes, groupIII: patients treated with captopril (25mg once daily) for their hypertension in addition to metformin (1000mg bid) groupIV: patients treated with captopril (25mg bid) for hypertension in addition to vildagliptin (50mg bid). At the end of the therapeutic period, then total cholesterol, LDL,serum Creatinine level, blood pressure and vascular endothelial growth factor (VEGF) levels in serum will be measured for different groups to estimate the benefits of one drug over the other one in protecting against cardiovascular risks for diabetic hypertensive patients..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control | No Intervention | healthy volunteers not suffering from diabetes or hypertension | |
| diabetic hypertensive recently diagnosed patients | No Intervention | recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet | |
| Metformin treated group | Other | diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes |
|
| Vildagliptin treated group | Other | diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin Pill | Drug | a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus |
|
| Measure | Description | Time Frame |
|---|---|---|
| benefit of reducing hypertension in diabetic hypertensive patients | blood pressure will be measured | 6 months |
| benefit of lowering cardiovascular risks for diabetic hypertensive patients | total lipid profile will be measured | 6 months |
| benefit of improving the condition of elevated blood pressure in patients through neovascularization | vascular endothelial growth factor level in serum will be measured | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| reducing obesity for diabetic patients | difference in body weight at the beginning and the end of the study will be measured | 6months |
| comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hekma A Abdel-Latif, Professor | cairo university faculty of pharmacy | Study Chair |
| Abdel Rahman M El-Naggar, Professor | Cairo University | Study Director |
| Mohammed F Elyamany, assistant professor | cairo university faculty of pharmacy | Study Director |
| Soha O Hassanin, lecturer | MTI unuversity faculty of pharmacy | Study Director |
| Atef Bassyouni, Professor | National institute of diabetes and endocrinology | Study Director |
| Dalia K Zaafar, assistant lecturer | MTI unuversity faculty of pharmacy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National institute of diabetes and endocrinology | Cairo | 11311 | Egypt |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| D000077597 | Vildagliptin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
| D009570 |
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| Vildagliptin 50 mg | Drug | Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus |
|
glycated hemoglobin will be measured
| 6 months |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Nitriles |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |