Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

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
    

Intervention name(s): Combination pulsatile Stendo3
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Vascular function; Pulsatile cuts; Type 2 diabetes; Endothelium; Cardiovascular risk; Vasomotricity; FMD (Flow Mediated Dilatation)