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

NCT02359461 | Completed

• 1 other identifier: CHU-0216
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes

Keywords

Vascular function; Pulsatile cuts; Type 2 diabetes; Endothelium; Cardiovascular risk; Vasomotricity; FMD (Flow Mediated Dilatation)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (26)

• Velocity of hyperemic response (VTI)

  at day 1

• Changes on Velocity of hyperemic response (VTI)

  at baseline

• Changes on circulating EMP levels (Endothelial MicroParticles)

  at baseline

• Stiffness of the central arteries by SphygmoCor

  at day 1

• Changes on Stiffness of the central arteries (SphygmoCor)

  at baseline

Study Arms (2)

Stendo group

EXPERIMENTAL

Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo

Device: Combination pulsatile Stendo3

control group

OTHER

Subjects will be randomized into two groups determining the sequence: stendo then control, or control then stendo

Device: Combination pulsatile Stendo3

Interventions

Combination pulsatile Stendo3 DEVICE

Stendo group; control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• STENDO, 17 rue du port 27400 LOUVIERS: collaborator

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (1)

• 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.

  PMID: 36550568 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2014
• First Posted: February 10, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 16, 2018

Record last verified: 2018-07

Locations

FR (1)