Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

MTI University120 enrolled

Overview

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..

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Interventions

Metformin PillDRUG

a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus

Vildagliptin 50 mgDRUG

Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

National institute of diabetes and endocrinology

Cairo, Egypt

Outcomes

Primary Outcomes

benefit of reducing hypertension in diabetic hypertensive patients

blood pressure will be measured

Time frame: 6 months

benefit of lowering cardiovascular risks for diabetic hypertensive patients

total lipid profile will be measured

Time frame: 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

Time frame: 6 months

Secondary Outcomes

reducing obesity for diabetic patients

difference in body weight at the beginning and the end of the study will be measured

Time frame: 6months

comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients

glycated hemoglobin will be measured

Time frame: 6 months

Data from ClinicalTrials.gov

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