Clinical trial NCT02293135: Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients
Official title: Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes ; endothelium stimulation
Lead sponsor: Stendo
Sponsor class: INDUSTRY
First posted: 2014-11-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peripheral microcirculation measured using Laser Doppler flowmetry
timeFrame: 30 minutes after the end of the Stendo session
Secondary outcomes:
measure: Arterial stiffness
timeFrame: 10 minutes after the end of Stendo session
measure: Heart Rate Variability (HRV)
timeFrame: 15 minutes after the end of Stendo session
measure: Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
timeFrame: 35 minutes after the end of Stendo session
measure: Reactive Hyperemia Index (RHI)
timeFrame: 45 minutes after the end of Stendo session
Other outcomes:
Locations:
city: Bondy
country: France
facility: Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition
Study officials:
affiliation: Hôpital Jean Verdier
name: Paul VALENSI, Professor
role: PRINCIPAL_INVESTIGATOR
References: