Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2017-08-01

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

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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..

Conditions

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Reducing the Elevated Blood Pressure for Diabetic Hypertensive Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Healthy control

healthy volunteers not suffering from diabetes or hypertension

Group Type NO_INTERVENTION

No interventions assigned to this group

diabetic hypertensive recently diagnosed patients

recently diagnosed patients suffers from diabetes type 2 and hypertension but didnot receive their proper treatment yet

Group Type NO_INTERVENTION

No interventions assigned to this group

Metformin treated group

diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes

Group Type OTHER

Metformin Pill

Intervention Type DRUG

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

Vildagliptin treated group

diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes

Group Type OTHER

Vildagliptin 50 mg

Intervention Type DRUG

Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Interventions

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Metformin Pill

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

Intervention Type DRUG

Vildagliptin 50 mg

Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus

Intervention Type DRUG

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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes