Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients
Conditions
Keywords
diabetes, Metformin, vildagliptin, hypertension, cardiovascular risk
Brief summary
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
Detailed description
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..
Interventions
DRUGMetformin Pill
a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus
Sponsors
MTI University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients suffering from moderate HTN and DM, their HbA1c ≥ 7 and age range between 40-60 years, treatment with diet alone, any combination of oral antidiabetic agents and/or insulin before admission
Exclusion criteria
* Clinical evidence of ischemic heart disease, chronic obstructive pulmonary disease, presence of diabetic ketoacidosis (DKA), patients admitted to intensive care unit (ICU), subjects expected to undergo surgery during the study period, patients with clinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0 mg/dL), systemic infections or pregnancy. Also, patients on medications known to interfere with the blood glucose level (either increasing or decreasing) were excluded from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| benefit of reducing hypertension in diabetic hypertensive patients | 6 months | blood pressure will be measured |
| benefit of lowering cardiovascular risks for diabetic hypertensive patients | 6 months | total lipid profile will be measured |
| benefit of improving the condition of elevated blood pressure in patients through neovascularization | 6 months | vascular endothelial growth factor level in serum will be measured |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| reducing obesity for diabetic patients | 6months | difference in body weight at the beginning and the end of the study will be measured |
| comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients | 6 months | glycated hemoglobin will be measured |
Countries
Egypt
Outcome results
None listed