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

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

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Verum Stendo session on V1 and Phantom Stendo session on V2; Device: Phantom Stendo session on V1 and Verum Stendo session on V2

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.

• Study Type: Interventional
• Enrollment (Anticipated): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bondy, France, 93143
    • Recruiting
    • Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Verum Stendo session on V1 and Phantom Stendo session on V2	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)
Experimental: Group 2; Phantom Stendo session on V1 and Verum Stendo session on V2	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Stendo
• Investigators: Principal Investigator: Paul VALENSI, Professor, Hôpital Jean Verdier

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: November 7, 2014
• First Submitted That Met QC Criteria: November 13, 2014
• First Posted (Estimate): November 18, 2014

Study Record Updates

• Last Update Posted (Estimate): May 22, 2015
• Last Update Submitted That Met QC Criteria: May 21, 2015
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Type 2 diabetes ; endothelium stimulation
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 2014-A00961-46