Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients (Diabete_1)

Stendo

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Device: Verum Stendo session on V1 and Phantom Stendo session on V2; Device: Phantom Stendo session on V1 and Verum Stendo session on V2

Study type: Interventional

Funder types: Industry

Identifiers

NCT02293135

2014-A00961-46

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

---

16 participants in 2 patient groups

Group 1

Experimental group

Description:

Verum Stendo session on V1 and Phantom Stendo session on V2

Treatment:

Device: Verum Stendo session on V1 and Phantom Stendo session on V2

Group 2

Experimental group

Description:

Phantom Stendo session on V1 and Verum Stendo session on V2

Treatment:

Device: Phantom Stendo session on V1 and Verum Stendo session on V2