Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2026-01-22 @ 12:31 PM
Study NCT ID:
NCT02359461
Status:
COMPLETED
Last Update Posted:
2018-07-16
First Post:
2014-12-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2
Sponsor:
University Hospital, Clermont-Ferrand
Organization:
Study Overview
Official Title:
Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STENDO3
Brief Summary:
The purpose of the study is to demonstrate an improvement of vascular function, and particularly dependent vasodilation flow and micro-vasculature, by STENDO for diabetic patients compared to a control period in crossover.
Action by shear stress causing vasodilation away from the microcirculation, STENDO should have a beneficial effect on vascular function in type 2 diabetics. These effects could be both treble just after the completion of a session with the device, and chronic with a potentiating effect of different sessions.
The investigators propose to study the different vascular function evaluation parameters we have, to highlight these acute and chronic changes. The investigators will also study the physical abilities to change topics and behavioral changes (spontaneous physical activity in particular) and impact on subject quality of life.
Action by shear stress causing vasodilation away from the microcirculation, STENDO should have a beneficial effect on vascular function in type 2 diabetics. These effects could be both treble just after the completion of a session with the device, and chronic with a potentiating effect of different sessions.
The investigators propose to study the different vascular function evaluation parameters we have, to highlight these acute and chronic changes. The investigators will also study the physical abilities to change topics and behavioral changes (spontaneous physical activity in particular) and impact on subject quality of life.
Detailed Description:
Patients will be screened during a visit V0. A collection of consent (informed consent form), clinical examination and a fasting blood test will be carried out during this visit. Laboratory tests run-in will be composed of: Cell Blood Count (CBC) platelets, renal function tests (serum electrolytes, urea and creatinine), liver function tests, fasting blood glucose levels and Lipid Profile). Measurement of blood Pressure (2 successive measurements at intervals of 5 min) and an electrocardiogram will be realized. The different information collected at enrollment will allow stratification of cardiovascular risk by reference integrators scores (ESC-SCORE (European Society of Cardiology Score) and Framingham Heart Study).
The feasibility of measures for study criteria (functional measurements and assays) will be tested fasting during this visit as the blood test.
V0: Patient Pre-Inclusion: J-5 and J-10
* Patient Information
* Collection of informed consent
* Demographic data, weight / height, waist circumference
* Interrogation,
* Clinical examination, Electrocardiogram
* Measuring blood pressure (2 successive measurements at intervals of 5 minutes)
* ESC-SCORE (European Society of Cardiology Score) and Framingham Heart Study
* Criteria inclusion / non inclusion
* Functional Measurements (which will validate the feasibility on the patient)
* Blood test fasting: Complete Blood Count (CBC) platelets, renal function tests (serum electrolytes, urea, creatinine), liver function, and blood sugar, Lipid Profile.
V1 - Day 1 of the study At V1, patients have a clinical examination and a blood test fasting for the determination of endothelial parameters (Endothelial Micro Particles EMP).
Subjects will be randomized into two groups determining the sequence: STENDO then control, or control then STENDO .
Furthermore, the functional measurements will be performed at baseline, the morning after fasting for 12 hours in a room specially dedicated to the study of vascular reactivity (calm, stable temperature between 23 and 25 ° C).
When the patient has the STENDO technical, biological and functional assessments will be renewed at the end of the first session STENDO (immediately after).
* Clinical examination
* Confirmation of inclusion
* Allocation of randomization
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile, Insulin
* Analysis of 24-hour urine: creatinine and microalbuminuria
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , Stiffness of the central arteries by SphygmoCor , Stiffness of the central arteries and peripheral arteries by pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Measurement of quality of life : Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
* Stendo Session 1 hour or 1 hour rest according to the randomization group
* Blood Sample: Endothelial Micro Particles (EMP) (if STENDO)
* Realization of functional measures: FMD, VTI, FLD, SphygmoCor, pOpmètre, fasting after the 1st STENDO session (if STENDO)
For three months, patients will benefit from one-hour sessions of STENDO three times a week.
V2 30 days after inclusion +/- 1 week and V3 60 days after inclusion +/- 1 week - intermediate visits V2 and V3 intermediate visits will avoid lost sight especially during the monitoring period.
An evaluation of the quality of life (SF-36 and VAS) and physical activity (IPAQ questionnaire control and collection of eMouve) will be made for the 2 groups.
V4 at 90 days after inclusion +/- 1 week or End of 1st period V4 visit will take place in the same way that the V1 visit the day after the last session STENDO (where applicable): clinical examination, functional measurements, fasting blood test, measures of physical functions.
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , Stiffness of the central arteries by SphygmoCor , Stiffness of the central arteries and peripheral arteries by pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
The time interval between V4 and V5 will be a minimum of 30 days to make a "wash-out" of stendo technique.
V5 : at least 120 days after inclusion, at least 30 days after "Wash-out" period Start of the 2nd period
V5 visit is the first visit of the second period of the crossover. This corresponds to the basal measurement of the second period.
The same assessments that will be carried out with V1 measuring parameters acute when the subject starts a period stendo
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , SphygmoCor, pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 Minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
If Stendo, for three months, patients will benefit from one-hour sessions of stendo three times a week.
V6 30 days +/- 1 week after the 2nd period onset and V7 60 days +/- 1 week after the 2nd period onset - intermediate visits The intermediate visits V6 and V7 will avoid lost sight especially during the monitoring period.
An evaluation of the Health-related quality of life by Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36)) and physical activity by International Physical Activity Questionnary - French Version (IPAQ) and Physical activity recorded by triaxial accelerometry (eMouve®) will be made for the 2 groups.
V8 90 days +/- 1 week End of second period Same measurements as the V4 visit. Signed by the investigator from the end of the study.
The day after the last session STENDO (where applicable): clinical examination, blood and functional measurements fasting blood test, physical function.
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , SphygmoCor, pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 Minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
* End of study forms
The feasibility of measures for study criteria (functional measurements and assays) will be tested fasting during this visit as the blood test.
V0: Patient Pre-Inclusion: J-5 and J-10
* Patient Information
* Collection of informed consent
* Demographic data, weight / height, waist circumference
* Interrogation,
* Clinical examination, Electrocardiogram
* Measuring blood pressure (2 successive measurements at intervals of 5 minutes)
* ESC-SCORE (European Society of Cardiology Score) and Framingham Heart Study
* Criteria inclusion / non inclusion
* Functional Measurements (which will validate the feasibility on the patient)
* Blood test fasting: Complete Blood Count (CBC) platelets, renal function tests (serum electrolytes, urea, creatinine), liver function, and blood sugar, Lipid Profile.
V1 - Day 1 of the study At V1, patients have a clinical examination and a blood test fasting for the determination of endothelial parameters (Endothelial Micro Particles EMP).
Subjects will be randomized into two groups determining the sequence: STENDO then control, or control then STENDO .
Furthermore, the functional measurements will be performed at baseline, the morning after fasting for 12 hours in a room specially dedicated to the study of vascular reactivity (calm, stable temperature between 23 and 25 ° C).
When the patient has the STENDO technical, biological and functional assessments will be renewed at the end of the first session STENDO (immediately after).
* Clinical examination
* Confirmation of inclusion
* Allocation of randomization
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile, Insulin
* Analysis of 24-hour urine: creatinine and microalbuminuria
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , Stiffness of the central arteries by SphygmoCor , Stiffness of the central arteries and peripheral arteries by pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Measurement of quality of life : Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
* Stendo Session 1 hour or 1 hour rest according to the randomization group
* Blood Sample: Endothelial Micro Particles (EMP) (if STENDO)
* Realization of functional measures: FMD, VTI, FLD, SphygmoCor, pOpmètre, fasting after the 1st STENDO session (if STENDO)
For three months, patients will benefit from one-hour sessions of STENDO three times a week.
V2 30 days after inclusion +/- 1 week and V3 60 days after inclusion +/- 1 week - intermediate visits V2 and V3 intermediate visits will avoid lost sight especially during the monitoring period.
An evaluation of the quality of life (SF-36 and VAS) and physical activity (IPAQ questionnaire control and collection of eMouve) will be made for the 2 groups.
V4 at 90 days after inclusion +/- 1 week or End of 1st period V4 visit will take place in the same way that the V1 visit the day after the last session STENDO (where applicable): clinical examination, functional measurements, fasting blood test, measures of physical functions.
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , Stiffness of the central arteries by SphygmoCor , Stiffness of the central arteries and peripheral arteries by pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
The time interval between V4 and V5 will be a minimum of 30 days to make a "wash-out" of stendo technique.
V5 : at least 120 days after inclusion, at least 30 days after "Wash-out" period Start of the 2nd period
V5 visit is the first visit of the second period of the crossover. This corresponds to the basal measurement of the second period.
The same assessments that will be carried out with V1 measuring parameters acute when the subject starts a period stendo
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , SphygmoCor, pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 Minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
If Stendo, for three months, patients will benefit from one-hour sessions of stendo three times a week.
V6 30 days +/- 1 week after the 2nd period onset and V7 60 days +/- 1 week after the 2nd period onset - intermediate visits The intermediate visits V6 and V7 will avoid lost sight especially during the monitoring period.
An evaluation of the Health-related quality of life by Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36)) and physical activity by International Physical Activity Questionnary - French Version (IPAQ) and Physical activity recorded by triaxial accelerometry (eMouve®) will be made for the 2 groups.
V8 90 days +/- 1 week End of second period Same measurements as the V4 visit. Signed by the investigator from the end of the study.
The day after the last session STENDO (where applicable): clinical examination, blood and functional measurements fasting blood test, physical function.
* Clinical examination
* Measuring blood pressure (2 successive measurements at 5min interval)
* Blood Sample: Endothelial Micro Particles (EMP), Creatinine, Glucose, Glycated Haemoglobin (HbA1c), Lipid profile analysis, Insulin
* Functional Measures: Flow-mediated dilatation (FMD), Velocity time integral (VTI), Laser Doppler Flowmetry (LDF) , SphygmoCor, pOpmètre, fasting
* Measurements of physical abilities: endurance of the quadriceps and Maximum Voluntary Contraction (MVC), MVC hands, Aerobic capacity (VO2 max), 6 Minutes Walk Test (6MWT), International Physical Activity Questionnary - French Version (IPAQ), Physical activity recorded by triaxial accelerometry (eMouve®),
* Visual Analogic Scale (VAS) and Short-form 36 Health survey (SF36).
* End of study forms
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: