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

Type 2 Diabetes Clinical Trial

— Diabete_1  

Official title:

Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02293135
• Other study ID #: 2014-A00961-46
• Status: Recruiting
• Phase: N/A
• First received: November 7, 2014
• Last updated: May 21, 2015
• Start date: November 2014
• Est. completion date: June 2015

Study information

• Verified date: November 2014
• Source: Stendo
• Contact: Paul VALENSI, Professor
• Phone: +33 1 48 02 65 97
• Email: paul.valensi[@]jvr.aphp.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• 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)
• 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

Locations

Country	Name	City	State
France	Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition	Bondy

Sponsors (1)

Lead Sponsor	Collaborator
Stendo

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peripheral microcirculation measured using Laser Doppler flowmetry	Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session	30 minutes after the end of the Stendo session	No
Secondary	Arterial stiffness	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	10 minutes after the end of Stendo session	No
Secondary	Heart Rate Variability (HRV)	HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records	15 minutes after the end of Stendo session	No
Secondary	Endothelium-dependant microvascular flow after local acetylcholine iontophoresis	3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry	35 minutes after the end of Stendo session	No
Secondary	Reactive Hyperemia Index (RHI)	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	45 minutes after the end of Stendo session	No