Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Device: Verum Stendo session on V1 and Phantom Stendo session on V2
* Device: Phantom Stendo session on V1 and Verum Stendo session on V2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Verum Stendo session on V1 and Phantom Stendo session on V2 | Device: Verum Stendo session on V1 and Phantom Stendo session on V2<br>* 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)<br>|
| Experimental: Group 2<br>Phantom Stendo session on V1 and Verum Stendo session on V2 | Device: Phantom Stendo session on V1 and Verum Stendo session on V2<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peripheral microcirculation measured using Laser Doppler flowmetry | Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session | 30 minutes after the end of the Stendo session | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 45 minutes after the end of Stendo session | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 2 diabetes ; endothelium stimulation