The Effect of Hybrid Closed-loop Systems on Markers of Endothelial, Myocardial and Vascular Function in Patients With Type 1 Diabetes.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pulse Wave Velocity
研究概览
简要总结
This is a prospective, non-randomized, observational cohort study conducted in adult patients with type 1 diabetes.Participants with poorly controlled T1D under multiple daily injection (MDI) treatment will be assigned to one of three treatment groups:
- hybrid closed-loop systems (HCLS) or
- Sodium glucose co-transporter 2 inhibitors (SGLT-2i) added to MDI or
- intensification of MDI treatment. Markers of endothelial and cardiovascular function will be assessed at baseline, at 6 and 12 months post-treatment. The primary objactive of the study is to evaluate the effect of HCLS on cardiovacular and endothelial function compared to MDI or SGLT-2i in T1D.
详细描述
Patients with type 1 diabetes mellitus (T1DM) present subclinical signs of vascular and endothelial dysfunction earlier compared to healthy individuals. Hybrid closed loop systems (HCLS) are currently the gold standard method for glycemic management, however, the data regarding its superiority in terms of the prevention of subclinical vascular and endothelial dysfunction are scarce. The aim of this study is to determine whether treatment with HCLS improves vascular and endothelial function compared to multiple daily injections (MDI) or Sodium glucose co-transporter 2 inhibitors (SGLT-2i) in patients with T1DM. Partcipants with poorly controlled T1DM under MDI treatment, will be assigned to receive either:
- HCLS or
- SGLT-2i as an add-on treatment to MDI or
- intensification of MDI treatment.
We will assess at baseline and 6 and 12 months post-treatment:
(i) glycemic parameters derived via continuous glucose monitoring (GGM) (ii) pulse wave velocity (PWV) (iii)central systolic and diastolic blood pressure (cSBP, cDBP) (iv) the perfused boundary region (PBR) of the sublingual arterial microvessels, as a marker of endothelial glycocalyx integrity.
(v) global longitudinal strain(GLS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •age >18 years
- •history of type 1 diabetes with diabetes duration > 5 years
- •HbA1c ≥ 7% and ≤ 10%
- •eGFR> 60ml/min/1,73m2.
排除标准
- •history of malignancy within the last 5 years
- •severe hepatic impairment
- •cardiovascular events within the recent three months
研究组 & 干预措施
HCL group
Patients will recieve hybrid closed loop system
干预措施: HCLS (Device)
SGLT-2i group
Patients will recieve SGLT-2i as add on treatment to multiple daily injections
干预措施: SGLT2 inhibitor (Drug)
MDI group
Patients will recieve intensification of MDI treatment.
干预措施: MDI (Drug)
结局指标
主要结局
Pulse Wave Velocity
时间窗: Baseline, Six Months, Twelve months
The investigators will assess pulse wave velocity as a marker of arterial stiffness at baseline, at six and twelve months post-treatment
Perfused Boundary Region
时间窗: Baseline, Six Months, Twelve months
The investigators will assess perfused boundary region as a marker of endothelial glycocalyx integrity at baseline, at six and twelve months post-treatment
Global Longitudinal Strain
时间窗: Baseline, Six Months, Twelve months
The investigators will assess global londitudinal strain as a marker of myocardial function at baseline, at six and twelve months post-treatment
次要结局
- Central Systolic Blood Pressure(Baseline, Six Months, Twelve months)
- Central Diastolic Blood Pressure(Baseline, Six Months, Twelve months)
- Augmentation Index(Baseline, Six Months, Twelve months)
- Flow mediated dilation(Baseline, Six Months, Twelve months)
- Coronary flow reserve(Baseline, Six Months, Twelve months)
研究者
VAIA LAMBADIARI
Professor of Internal Medicine-Endocrinology
Attikon Hospital