search
Back to results

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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Verum Stendo session on V1 and Phantom Stendo session on V2
Phantom Stendo session on V1 and Verum Stendo session on V2
Sponsored by
Stendo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Type 2 diabetes ; endothelium stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie NutritionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group 1

Group 2

Arm Description

Verum Stendo session on V1 and Phantom Stendo session on V2

Phantom Stendo session on V1 and Verum Stendo session on V2

Outcomes

Primary Outcome Measures

Peripheral microcirculation measured using Laser Doppler flowmetry
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session

Secondary Outcome Measures

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
Heart Rate Variability (HRV)
HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry
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

Full Information

First Posted
November 7, 2014
Last Updated
May 21, 2015
Sponsor
Stendo
search

1. Study Identification

Unique Protocol Identification Number
NCT02293135
Brief Title
Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stendo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Type 2 diabetes ; endothelium stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1
Arm Type
Experimental
Arm Description
Verum Stendo session on V1 and Phantom Stendo session on V2
Arm Title
Group 2
Arm Type
Experimental
Arm Description
Phantom Stendo session on V1 and Verum Stendo session on V2
Intervention Type
Device
Intervention Name(s)
Verum Stendo session on V1 and Phantom Stendo session on V2
Intervention Description
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
Intervention Name(s)
Phantom Stendo session on V1 and Verum Stendo session on V2
Intervention Description
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
Primary Outcome Measure Information:
Title
Peripheral microcirculation measured using Laser Doppler flowmetry
Description
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
Time Frame
30 minutes after the end of the Stendo session
Secondary Outcome Measure Information:
Title
Arterial stiffness
Description
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
Time Frame
10 minutes after the end of Stendo session
Title
Heart Rate Variability (HRV)
Description
HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records
Time Frame
15 minutes after the end of Stendo session
Title
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
Description
3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry
Time Frame
35 minutes after the end of Stendo session
Title
Reactive Hyperemia Index (RHI)
Description
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
Time Frame
45 minutes after the end of Stendo session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul VALENSI, Professor
Phone
+33 1 48 02 65 97
Email
paul.valensi@jvr.aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Badreddine MERIOUD, MD
Phone
+ 33 148 02 65 99
Email
badreddine.merioud@jvr.ap-hop-paris.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul VALENSI, Professor
Organizational Affiliation
Hôpital Jean Verdier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition
City
Bondy
ZIP/Postal Code
93143
Country
France
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs