Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2

Type 2 Diabetes Clinical Trial

— STENDO3  

Official title:

Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359461
• Other study ID #: CHU-0216
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: June 2018

Study information

• Verified date: July 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: June 2018
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with type 2 diabetes

• Age between = 18 and = 75 years

• Diagnosis of diabetes> 2 years

• Asymptomatic on the cardiovascular

• No known heart disease

• ECG in sinus rythm with no signs suggestive of heart disease

• Absence of myocardial ischemia demonstrated by a stress test, myocardial scintigraphy or stress ultrasound

• Oral treatment with antidiabetic and / or insulin and / or incretin

• Affiliated with a social security scheme

• Having signed an informed consent

Exclusion Criteria:

• Type 1 diabetes

• Previous history of cardiomyopathy or ischemic heart disease

• Absence of sinus rythm

• ECG that suggest heart disease

• Electrical malfunction during the exercise test

• Hemo-dynamically significant valvular pathology

• Severe renal impairment (GFR <30 ml / min / 1.73m²)

• Uncontrolled hypertension: SBP = 140 mm Hg or DBP = 90 mm Hg The introduction or modification of antihypertensive treatment leads to the inability to include the subject for two months, the time to reach a new balance.

• Comorbidity involving life-threatening

• BMI> 40 kg /m2

• Peripheral vascular disease:

• Stage 3

• IPS (Index of systolic pressures) uninterpretable for which a doppler has diagnosed arteritis

• IPS lowered below 0.80

• Proximal or distal arterial bypass (or sub-popliteal fossa) or aortic prosthesis

• Deep vein thrombosis or superficial scalable recent lower limb or having a pulmonary embolism for less than one year

• Unhealed wound of the lower limbs or abdomen (ulcer, saphenectomy scars, surgical scarpa or abdominal approach)

• Disabling painful symptomatology of the lower extremities (paraesthesia, neuropathy, myalgia)

• Treaty by selective phosphodiesterase inhibitor (Sildenafil ...)

• Patients with cognitive impairment disabling

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Device:
• Combination pulsatile Stendo3

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	STENDO, 17 rue du port 27400 LOUVIERS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from Baseline in endothelial function of the large vessels by FMD (Flow Mediated Dilatation)	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study) separated by 1 month wash-out period	at baseline
Secondary	Velocity of hyperemic response (VTI)		at day 1
Secondary	Changes on Velocity of hyperemic response (VTI)	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at baseline
Secondary	Changes on circulating EMP levels (Endothelial MicroParticles)	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at baseline
Secondary	Stiffness of the central arteries by SphygmoCor		at day 1
Secondary	Changes on Stiffness of the central arteries (SphygmoCor)	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at baseline
Secondary	Changes on Stiffness of the central arteries and peripheral arteries (finger / toe) (pOpmètre)		at baseline
Secondary	Muscular Endurance quadriceps (in seconds)	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at day 1
Secondary	Changes on Maximal voluntary contraction quadriceps (MVC_q in Newton)	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at visits just before and after 3 months
Secondary	Changes on Maximal voluntary contraction hand (MVC_h in Newton)	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Physical activity detected by a physical activity Questionnaire (IPAQ short)		at day 1
Secondary	Changes on Aerobic capacity (VO2max)	measured at visits just before and after 3 months of STENDO (cross-over part of the study)	at visits just before and after 3 months of STENDO
Secondary	Changes on 6-minute walk test (6MWT)	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment (Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Changes on Physical activity assessed by the International Physical Activity Questionnaire (IPAQ short)	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment (Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on Physical activity recorded by triaxial accelerometry (eMouve®)	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment (Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on Body composition (Fat mass, Muscle mass, Hydric mass) measured by impedancemetry	measured at visits measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at visits measured at visits just before and after 3 months of STENDO
Secondary	Assessment of medications and posology	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment ( Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on Health-related Quality of life assessed by the patient on a visual analogue scale (EVA_Quality of life)	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment ( Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on Health related Quality of life according to the SF 36 Health survey assessed by patients	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment ( Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on Health related quality of life using Visual analogue scale (VAS ) assessed by patients	measured at visits monthly during the 3 months of STENDO (cross-over part of the study) and during the 3 months of control treatment (Parallel part of the study)	at visits monthly during the 3 months of STENDO
Secondary	Changes on fasting Glycemia	measured at baseline, then fasting at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at baseline
Secondary	Changes on Insulin serum levels	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Changes on Glycated Haemoglobin serum levels (HbA1c)	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Changes on Lipid profile on serum levels (total cholesterol, LDL / HDL, trigycérides)	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Changes on Serum creatinine levels	measured at visits just before and after 3 months of STENDO (cross-over part of the study) and before and after 3 months of control treatment ( Parallel part of the study)	at visits just before and after 3 months of STENDO
Secondary	Assessment of Urinary creatinine levels		at day 1
Secondary	Assessment of microalbuminuria levels of 24 hours		at day 1