Type 2 DiabetesSTENDO3NCT02359461
Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2
A study testing Combination pulsatile Stendo3 in people with Type 2 Diabetes, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Combination pulsatile Stendo3
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Combination pulsatile Stendo3
- Keywords
- Vascular function, Pulsatile cuts, Type 2 diabetes, Endothelium, Cardiovascular risk, Vasomotricity, FMD (Flow Mediated Dilatation)
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination pulsatile Stendo3Device
| Study group | Role | What they receive |
|---|---|---|
| Stendo group | Experimental | Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo Receives: Device: Combination pulsatile Stendo3 |
| control group | Other | Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo Receives: Device: Combination pulsatile Stendo3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline
Secondary outcomes (26)
Velocity of hyperemic response (VTI)
Measured: at day 1
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)
Measured: at baseline
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)
Measured: at baseline
Stiffness of the central arteries by SphygmoCor
Measured: at day 1
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)
Measured: at baseline
Changes on Stiffness of the central arteries and peripheral arteries (finger / toe) (pOpmètre)
Measured: at baseline
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)
Measured: at day 1
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)
Measured: at visits just before and after 3 months
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)
Measured: at visits just before and after 3 months of STENDO
Physical activity detected by a physical activity Questionnaire (IPAQ short)
Measured: at day 1
Changes on Aerobic capacity (VO2max)
measured at visits just before and after 3 months of STENDO (cross-over part of the study)
Measured: at visits just before and after 3 months of STENDO
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)
Measured: at visits just before and after 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at visits measured at visits just before and after 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at visits monthly during the 3 months of STENDO
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)
Measured: at baseline
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)
Measured: at visits just before and after 3 months of STENDO
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)
Measured: at visits just before and after 3 months of STENDO
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)
Measured: at visits just before and after 3 months of STENDO
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)
Measured: at visits just before and after 3 months of STENDO
Assessment of Urinary creatinine levels
Measured: at day 1
Assessment of microalbuminuria levels of 24 hours
Measured: at day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- STENDO, 17 rue du port 27400 LOUVIERS
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359461
- Sponsor's protocol ID
- CHU-0216
- Acronym
- STENDO3
- Status last verified
- Jul 2018
- First submitted
- 23 Dec 2014
- Last updated
- 16 Jul 2018
- Results posted
- No
Publications
Valensi P, Barber-Chamoux N, Rezki A, Lambert C, Pereira B, Duale C, Delmas D, Duclos M. Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies. Cardiovasc Diabetol. 2022 Dec 22;21(1):286. doi: 10.1186/s12933-022-01710-6.
PubMed 36550568
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Pulsatile Cuts Stendo3 on Vascular Function Patients With Diabetes Type 2
- ClinicalTrials.gov ID
- NCT02359461
- Acronym / sponsor ID
- STENDO3 / CHU-0216
- Conditions
- Type 2 Diabetes
- Keywords
- Vascular function, Pulsatile cuts, Type 2 diabetes, Endothelium, Cardiovascular risk, Vasomotricity, FMD (Flow Mediated Dilatation)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- STENDO, 17 rue du port 27400 LOUVIERS
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 10 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stendo group | Experimental | Device: Combination pulsatile Stendo3Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo |
| control group | Other | Device: Combination pulsatile Stendo3Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with type 2 diabetes
- Age between ≥ 18 and ≤ 75 years
- Diagnosis of diabetes> 2 years
- Asymptomatic on the cardiovascular
- No known heart disease
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combination pulsatile Stendo3 | Device | Stendo group, control group |
Primary outcome
Changes from Baseline in endothelial function of the large vessels by FMD (Flow Mediated Dilatation)
Time frame: at baseline
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
26 secondary outcomes
Velocity of hyperemic response (VTI)
Time frame: at day 1
Changes on Velocity of hyperemic response (VTI)
Time frame: at baseline
Changes on circulating EMP levels (Endothelial MicroParticles)
Time frame: at baseline
Stiffness of the central arteries by SphygmoCor
Time frame: at day 1
Changes on Stiffness of the central arteries (SphygmoCor)
Time frame: at baseline
Changes on Stiffness of the central arteries and peripheral arteries (finger / toe) (pOpmètre)
Time frame: at baseline
Muscular Endurance quadriceps (in seconds)
Time frame: at day 1
Changes on Maximal voluntary contraction quadriceps (MVC_q in Newton)
Time frame: at visits just before and after 3 months
Changes on Maximal voluntary contraction hand (MVC_h in Newton)
Time frame: at visits just before and after 3 months of STENDO
Physical activity detected by a physical activity Questionnaire (IPAQ short)
Time frame: at day 1
Changes on Aerobic capacity (VO2max)
Time frame: at visits just before and after 3 months of STENDO
Changes on 6-minute walk test (6MWT)
Time frame: at visits just before and after 3 months of STENDO
Changes on Physical activity assessed by the International Physical Activity Questionnaire (IPAQ short)
Time frame: at visits monthly during the 3 months of STENDO
Changes on Physical activity recorded by triaxial accelerometry (eMouve®)
Time frame: at visits monthly during the 3 months of STENDO
Changes on Body composition (Fat mass, Muscle mass, Hydric mass) measured by impedancemetry
Time frame: at visits measured at visits just before and after 3 months of STENDO
Assessment of medications and posology
Time frame: at visits monthly during the 3 months of STENDO
Changes on Health-related Quality of life assessed by the patient on a visual analogue scale (EVA_Quality of life)
Time frame: at visits monthly during the 3 months of STENDO
Changes on Health related Quality of life according to the SF 36 Health survey assessed by patients
Time frame: at visits monthly during the 3 months of STENDO
Changes on Health related quality of life using Visual analogue scale (VAS ) assessed by patients
Time frame: at visits monthly during the 3 months of STENDO
Changes on fasting Glycemia
Time frame: at baseline
Changes on Insulin serum levels
Time frame: at visits just before and after 3 months of STENDO
Changes on Glycated Haemoglobin serum levels (HbA1c)
Time frame: at visits just before and after 3 months of STENDO
Changes on Lipid profile on serum levels (total cholesterol, LDL / HDL, trigycérides)
Time frame: at visits just before and after 3 months of STENDO
Changes on Serum creatinine levels
Time frame: at visits just before and after 3 months of STENDO
Assessment of Urinary creatinine levels
Time frame: at day 1
Assessment of microalbuminuria levels of 24 hours
Time frame: at day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2018.
- Derived from this study: PubMed 36550568Valensi P, Barber-Chamoux N, Rezki A, Lambert C, Pereira B, Duale C, Delmas D, Duclos M. Effects of single and multiple sessions of lower body diastole-synchronized compressions using a pulsating pneumatic suit on endothelium function and metabolic parameters in patients with type 2 diabetes: two controlled cross-over studies. Cardiovasc Diabetol. 2022 Dec 22;21(1):286. doi: 10.1186/s12933-022-01710-6.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination pulsatile Stendo3 in people with Type 2 Diabetes, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in endothelial function of the large vessels by FMD (Flow Mediated Dilatation) (time frame: at baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02359461, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2018.