Study of Endothelial Glycocalyx and Vascular Function in Patients With Type 2 Diabetes and Albuminuria After Administration of Dulaglutide and Dapagliflozin vs DPP-4 Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- UACR
研究概览
简要总结
Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness, UACR, endothelial glycocalyx and global longitudinal strain will be assesed at baseline, 4 and 12 months.
详细描述
Patients with Type 2 Diabetes Mellitus and albuminuria will be randomised eitheer to dulaglutide and dapagliflozin combination or DPP-4 inhibitor, as an add-on treatment to metformin. Arterial stiffness via pulse wave velocity (PWV), UACR, endothelial glycocalyx via Microscan camera, and global longitudinal strain via echocardiography will be assesed at baseline, 4 and 12 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes mellitus Albuminuria HbA1c: 7-10% eGFR> 60 ml/min
排除标准
- •Type 1 diabetes mellitus Inflammation, chronic or acute Established cardiovascular disease Malignancy within the last 5 years
研究组 & 干预措施
Patients receiving DPP-4i
Patients with T2DM and albuminuria receiving DPP-4i
干预措施: DPP-4 Inhibitors (Drug)
Patients receiving dulaglutide and dapagliflozin
Patients with T2DM and albuminuria receiving dulaglutide and dapagliflozin
干预措施: Dulaglutide (Drug)
结局指标
主要结局
UACR
时间窗: 4 and 12 months
UACR change after 4 and 12 months of treatment
PWV
时间窗: 4 and 12 months
PWV change after 4 and 12 months of treatment
PBR
时间窗: 4 and 12 months
PBR change after 4 and 12 months of treatment
GLS
时间窗: 4 and 12 months
GLS change after 4 and 12 months of ttreatment
次要结局
未报告次要终点
研究者
VAIA LAMBADIARI
Professor of Internal Medicine and Endocrinology
Attikon Hospital