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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Verum Stendo session on V1 and Phantom Stendo session on V2 |
|
| Group 2 | Experimental | Phantom Stendo session on V1 and Verum Stendo session on V2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Verum Stendo session on V1 and Phantom Stendo session on V2 | Device | 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) |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paul VALENSI, Professor | Contact | +33 1 48 02 65 97 | paul.valensi@jvr.aphp.fr | |
| Badreddine MERIOUD, MD | Contact | + 33 148 02 65 99 | badreddine.merioud@jvr.ap-hop-paris.fr |
| Name | Affiliation | Role |
|---|---|---|
| Paul VALENSI, Professor | Hôpital Jean Verdier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition | Recruiting | Bondy | 93143 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36550568 | Derived | Valensi P, Barber-Chamoux N, Rezki A, Lambert C, Pereira B, Duale C, Delmas D, Duclos M. Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies. Cardiovasc Diabetol. 2022 Dec 22;21(1):286. doi: 10.1186/s12933-022-01710-6. |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Phantom Stendo session on V1 and Verum Stendo session on V2 | Device | 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 |
|
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 |
| D004700 | Endocrine System Diseases |