Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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..

Official Title
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Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension

Conditions
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Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Intervention / Treatment
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* Drug: Metformin Pill
* Drug: Vildagliptin 50 mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Healthy control<br>healthy volunteers not suffering from diabetes or hypertension | |
| No Intervention: diabetic hypertensive recently diagnosed patients<br>recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet | |
| Other: Metformin treated group<br>diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes | Drug: Metformin Pill<br>* a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus<br>|
| Other: Vildagliptin treated group<br>diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes | Drug: Vildagliptin 50 mg<br>* Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | glycated hemoglobin will be measured | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, Metformin, vildagliptin, hypertension, cardiovascular risk