Type 2 DiabetesDiabete_1NCT02293135
Evaluation of Stendo Pulsating Suit on Microcirculation and Endothelial Function in Diabetic Patients
A study testing Verum Stendo session on V1 and Phantom Stendo session on V2 and Phantom Stendo session on V1 and Verum Stendo session on V2 in people with Type 2 Diabetes, run by Stendo at 1 site in France.
Trial 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 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?
- Verum Stendo session on V1 and Phantom Stendo session on V2 and Phantom Stendo session on V1 and Verum Stendo session on V2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2014to Jun 2015
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Jean Verdier, Service d'Endocrinologie Diabétologie Nutrition
Bondy, 93143
About this study
Official title: Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication
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
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Verum Stendo session on V1 and Phantom Stendo session on V2, Phantom Stendo session on V1 and Verum Stendo session on V2
- Keywords
- Type 2 diabetes ; endothelium stimulation
- 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.
Verum Stendo session on V1 and Phantom Stendo session on V2Device
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)
Phantom Stendo session on V1 and Verum Stendo session on V2Device
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
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Verum Stendo session on V1 and Phantom Stendo session on V2 Receives: Device: Verum Stendo session on V1 and Phantom Stendo session on V2 |
| Group 2 | Experimental | Phantom Stendo session on V1 and Verum Stendo session on V2 Receives: Device: Phantom Stendo session on V1 and Verum Stendo session on V2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral microcirculation measured using Laser Doppler flowmetry
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
Measured: 30 minutes after the end of the Stendo session
Secondary outcomes (4)
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
Measured: 10 minutes after the end of Stendo session
Heart Rate Variability (HRV)
HRV is calculated from continuous noninvasive arterial pressure records and continuous high resolution 3-lead, 6channel ECG records
Measured: 15 minutes after the end of Stendo session
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
3 minutes Area Under Curve (AUC) of the peripheral microcirculation using Laser Doppler flowmetry
Measured: 35 minutes after the end of Stendo session
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
Measured: 45 minutes after the end of Stendo session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stendo
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul VALENSI, Professor, Principal investigator, Hôpital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02293135
- Sponsor's protocol ID
- 2014-A00961-46
- Acronym
- Diabete_1
- Status last verified
- Nov 2014
- First submitted
- 7 Nov 2014
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
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 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Action of the Stendo Pulsating Suit on Peripheral Microcirculation and on Endothelial Function in Diabetic Patients Without Complication
- ClinicalTrials.gov ID
- NCT02293135
- Acronym / sponsor ID
- Diabete_1 / 2014-A00961-46
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes ; endothelium stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- StendoIndustry (pharma, biotech, devices)
- Study start
- Nov 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Nov 2014 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: Verum Stendo session on V1 and Phantom Stendo session on V2Verum Stendo session on V1 and Phantom Stendo session on V2 |
| Group 2 | Experimental | Device: Phantom Stendo session on V1 and Verum Stendo session on V2Phantom Stendo session on V1 and Verum Stendo session on V2 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Type 1 diabetic Patient
- Antecedent of cardiomyopathy, cardiac ischemia or valvulopathy
- Severe kidney failure
- Non controlled hypertension (> 160/100mm Hg)
- Cardiac arrhythmia
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 |
|---|---|---|
| Verum Stendo session on V1 and Phantom Stendo session on V2On 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) | Device | Group 1 |
| Phantom Stendo session on V1 and Verum Stendo session on V2On 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 | Device | Group 2 |
Primary outcome
Peripheral microcirculation measured using Laser Doppler flowmetry
Time frame: 30 minutes after the end of the Stendo session
Change in % of the peripheral cutaneous microcirculation using laser Doppler flowmetry after one Stendo pulsating suit session
4 secondary outcomes
Arterial stiffness
Time frame: 10 minutes after the end of Stendo session
Heart Rate Variability (HRV)
Time frame: 15 minutes after the end of Stendo session
Endothelium-dependant microvascular flow after local acetylcholine iontophoresis
Time frame: 35 minutes after the end of Stendo session
Reactive Hyperemia Index (RHI)
Time frame: 45 minutes after the end of Stendo session
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- 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.
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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.
Paul VALENSI, Professor principal investigator
Hôpital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum Stendo session on V1 and Phantom Stendo session on V2 and Phantom Stendo session on V1 and Verum Stendo session on V2 in people with Type 2 Diabetes, run by Stendo 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 4 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 May 2015. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul VALENSI, Professor (+33 1 48 02 65 97, paul.valensi@jvr.aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral microcirculation measured using Laser Doppler flowmetry (time frame: 30 minutes after the end of the Stendo session). 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 NCT02293135, 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 22 May 2015.