Type 2 Diabetes
Conditions
Keywords
Type 2 diabetes ; endothelium stimulation
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.
Interventions
DEVICEVerum Stendo session on V1 and Phantom Stendo session on V2
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)
DEVICEPhantom Stendo session on V1 and Verum Stendo session on V2
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
Sponsors
Stendo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactPaul VALENSI, Professor
Backup ContactBadreddine MERIOUD, MD
Outcome results
None listed