Comparative Efficacy and Safety of Vildagliptin Versus Metformin in Reduction of Cardiovascular Complications in Type 2 Diabetic Patients With Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- benefit of reducing hypertension in diabetic hypertensive patients
研究概览
简要总结
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
详细描述
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..
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Metformin treated group
diabetic hypertensive patients which were treated with captopril for their hypertension and metformin for their diabetes
干预措施: Metformin Pill (Drug)
Vildagliptin treated group
diabetic hypertensive patients which were treated with captopril for their hypertension and vildagliptin for their diabetes
干预措施: Vildagliptin 50 mg (Drug)
结局指标
主要结局
benefit of reducing hypertension in diabetic hypertensive patients
时间窗: 6 months
blood pressure will be measured
benefit of lowering cardiovascular risks for diabetic hypertensive patients
时间窗: 6 months
total lipid profile will be measured
benefit of improving the condition of elevated blood pressure in patients through neovascularization
时间窗: 6 months
vascular endothelial growth factor level in serum will be measured
次要结局
- reducing obesity for diabetic patients(6months)
- comparing the anti-hyperglycemic effect of each drug for diabetic hypertensive patients(6 months)
研究者
Dalia Kamal Zaafar Ali
assistant lecturer of pharmacology and toxicology
MTI University