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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
On the firt V1 visit, the patient will receive the verum Stendo session ; then on V2 visit ((V1 + 13 days +/- 2), the patient will receive the verum Stendo session On the firt visit, V1 the patient will have a phantom Stendo session (no pressure will be applied)
On the firt V1 visit, the patient will have a phantom Stendo session (no pressure will be applied) ; then on V2 visit ((V1 + 13 dayx +/- 2), the patient will receive the verum Stendo session
Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition
Bondy, France
RECRUITINGPeripheral microcirculation measured using Laser Doppler flowmetry
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
Time frame: 30 minutes after the end of the Stendo session
Arterial stiffness
Change of arterial stiffness using an applanation tonometry device after one Stendo pulsating suit session; Augmentation Index and sub-endocardial viability ratio will also be assessed
Time frame: 10 minutes after the end of Stendo session
Heart Rate Variability (HRV)
HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records
Time frame: 15 minutes after the end of Stendo session
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry
Time frame: 35 minutes after the end of Stendo session
Reactive Hyperemia Index (RHI)
RHI is the post-to-pre occlusion Peripheral Arterial Tone (PAT) signal ratio in the occluded arm, relative to the same ratio in the control arm
Time frame: 45 minutes after the end of Stendo session
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