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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group 1

Verum Stendo session on V1 and Phantom Stendo session on V2

Group Type EXPERIMENTAL

Verum Stendo session on V1 and Phantom Stendo session on V2

Intervention Type 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)

Group 2

Phantom Stendo session on V1 and Verum Stendo session on V2

Group Type EXPERIMENTAL

Phantom Stendo session on V1 and Verum Stendo session on V2

Intervention Type 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

Interventions

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Verum 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)

Intervention Type DEVICE

Phantom 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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No