Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients
- Conditions
- Type 2 Diabetes
- Interventions
- Device: Verum Stendo session on V1 and Phantom Stendo session on V2Device: Phantom Stendo session on V1 and Verum Stendo session on V2
- Registration Number
- NCT02293135
- Lead Sponsor
- Stendo
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Group 1 Verum Stendo session on V1 and Phantom Stendo session on V2 Verum Stendo session on V1 and Phantom Stendo session on V2 Group 2 Phantom Stendo session on V1 and Verum Stendo session on V2 Phantom Stendo session on V1 and Verum Stendo session on V2
- Primary Outcome Measures
Name Time Method Peripheral microcirculation measured using Laser Doppler flowmetry 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
- Secondary Outcome Measures
Name Time Method Heart Rate Variability (HRV) 15 minutes after the end of Stendo session HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis 35 minutes after the end of Stendo session 3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry
Arterial stiffness 10 minutes after the end of Stendo session 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
Reactive Hyperemia Index (RHI) 45 minutes after the end of Stendo session 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
Trial Locations
- Locations (1)
Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition
🇫🇷Bondy, France