The Effects of Empagliflozin on Functional and Structural Arterial Wall Characteristics
试验速览
- 阶段
- 4 期
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Arterial function
研究概览
简要总结
Introduction: Diabetes mellitus is characterized by impaired arterial function and high incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs, SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now, direct effect of empagliflozin on arterial function and its comparison to metformin was not studied yet.
Aim: The aim of the present study is to explore and compare potential direct effects of empagliflozin and metformin on arterial functional and structural arterial wall characteristics in patients with type 1 diabetes mellitus.
Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1) empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25 mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12 weeks treatment, arterial function is assessed: endothelial function (brachial artery flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness (β-stiffness)).
详细描述
Introduction: Diabetes mellitus is characterized by impaired arterial function and high incidence of cardiovascular events. Metformin and most recent antidiabetic groups of drugs, SGLT2 inhibitors, were in previous studies shown to reduce cardiovascular events. Until now, direct effect of empagliflozin on arterial function and its comparison to metformin was not studied yet.
Aim: The aim of the present study is to explore and compare potential direct effects of empagliflozin and metformin on arterial functional and structural arterial wall characteristics in patients with type 1 diabetes mellitus.
Methods: Patients with type 1 diabetes mellitus are randomized into four groups: 1) empagliflozin (25 mg daily), 2) metformin (2000 mg daily), 3) combination (empagliflozin 25 mg daily and metformin 2000 mg daily) and 4) control (placebo). At inclusion and after 12 weeks treatment, arterial function is assessed: endothelial function (brachial artery flow-mediated dilation (FMD), reactive hyperemia index (RHI)) and arterial stiffness (carotid pulse wave velocity (PWV), carotid-femoral PWV (cfPWV) and common carotid artery stiffness (β-stiffness)).
Background:
Diabetes mellitus is characterized by chronic hyperglycaemia causing chronic microvascular and macrovascular complications. Among the microvascular complications, diabetic retinopathy, neuropathy and nephropathy are included. Macrovascular complications include atherosclerotic brain-vascular disease, coronary disease and peripheral arterial disease. Chronic complications of diabetes pose a greater risk of disability, development of blindness, renal failure, neuropathy and cardiovascular disease. Consequently, a good glycemic control is crucial to protect the patients from the development of chronic complications. In this regard, glycemic control is of primary importance, as well as the choice of treatment that can further improve the functioning of the arteries and thus protect against the onset of cardiovascular damage or complications.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diabetes mellitus type 1
排除标准
- •diagnosed advanced heart, kidney or liver failure
- •benign prostatic hyperplasia
- •prostatic carcinoma
- •frequent urinary tract infections
- •non-type 1 diabetes mellitus
研究组 & 干预措施
*empagliflozin*
empagliflozin 25 mg daily for 12 weeks, once daily, by mouth
干预措施: Empagliflozin 25mg (Drug)
*metformin*
metformin 2000 mg daily for 12 weeks, once daily, by mouth
干预措施: Metformin (Drug)
*empagliflozin/metformin*
empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth
干预措施: Empagliflozin 25mg (Drug)
*empagliflozin/metformin*
empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth
干预措施: Metformin (Drug)
*empagliflozin/metformin*
empagliflozin 25 mg daily and metformin 2000 mg daily for 12 weeks, by mouth
干预措施: Empagliflozin/Metformin (Drug)
*placebo*
placebo for 12 weeks, once daily with water, by mouth
干预措施: Placebos (Drug)
结局指标
主要结局
Arterial function
时间窗: the change of arterial function from baseline to 12 weeks of treatment
Endothelial function and arterial stiffness will be measured.
次要结局
- Glycemic control(the change of HbA1c from baseline to 12 weeks of treatment)
研究者
Mojca Lunder
MD, PhD, Research assistant at the Department of Endocrinology, Diabetes and Metabolic Diseases
University Medical Centre Ljubljana