Metformin Versus Vildagliptin for Diabetic Hypertensive Patients

Last updated: August 15, 2017
Sponsor: MTI University
Overall Status: Completed

Phase

4

Condition

Stress

Circulation Disorders

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT03253562
IDE00217
  • Ages 40-60
  • Female
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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 agentsand/or insulin before admission

Exclusion

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 withclinically relevant hepatic disease, impaired renal function (serum creatinine ≥3.0mg/dL), systemic infections or pregnancy. Also, patients on medications known tointerfere with the blood glucose level (either increasing or decreasing) were excludedfrom the study.

Study Design

Total Participants: 120
Study Start date:
February 01, 2017
Estimated Completion Date:
August 01, 2017

Study 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..

Connect with a study center

  • National institute of diabetes and endocrinology

    Cairo, 11311
    Egypt

    Site Not Available

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