Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Peripheral microcirculation measured using Laser Doppler flowmetry
研究概览
简要总结
The action of one Stendo pulsating suit session will be evaluated on 16 type 2 diabetic patients referred on the diabetic consultations. The effects of one Stendo pulsating suit session system will be assessed on the peripheral cutaneous microcirculation and on endothelial functions
详细描述
The role of the endothelium in micro-vascular system is mediated by synthesis and release of numerous substances that act on the smooth muscle fibers. The release of these products is modulated, in turn, by various circulating molecules, by autonomic nervous system and by local mechanical factors such as shear stress.
The type 2 diabetes leads to early vascular redesign with the onset of endothelial dysfunction and the worsening of the arterial stiffness.
These anomalies, well correlated with the cardiovascular risks, are currently investigated in the department of Endocrinology, Diabetes, and Nutrition at the Jean Verdier Hospital. The analysis methods allow identifying early modifications in response to various drugs, nutritional or physical stimuli.
The aim of this study is therefore to evidence a peripheral microcirculation and endothelial function improvement in type 2 diabetic patient in comparison to a cross-over control session.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patient
- •Diagnosis of diabetes > 1 year
- •HBA1c between 6 and 8,5
- •Treated with oral anti-diabetic, insulin and/or incretins which can be stayed unchanged during the 2-week study
排除标准
- •Type 1 diabetic Patient
- •Antecedent of cardiomyopathy, cardiac ischemia or valvulopathy
- •Severe kidney failure
- •Non controlled hypertension (> 160/100mm Hg)
- •Cardiac arrhythmia
- •Severe respiratory failure
- •Patient with an advanced obstructive arterial disease
- •Patient with a recent and progressive deep venous thrombosis
研究组 & 干预措施
Group 1
Verum Stendo session on V1 and Phantom Stendo session on V2
干预措施: Verum Stendo session on V1 and Phantom Stendo session on V2 (Device)
Group 2
Phantom Stendo session on V1 and Verum Stendo session on V2
干预措施: Phantom Stendo session on V1 and Verum Stendo session on V2 (Device)
结局指标
主要结局
Peripheral microcirculation measured using Laser Doppler flowmetry
时间窗: 30 minutes after the end of the Stendo session
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
次要结局
- Heart Rate Variability (HRV)(15 minutes after the end of Stendo session)
- Endothelium-dependant microvascular flow after local acetylcholine iontophoresis(35 minutes after the end of Stendo session)
- Arterial stiffness(10 minutes after the end of Stendo session)
- Reactive Hyperemia Index (RHI)(45 minutes after the end of Stendo session)