Clinical trial
Comparative Evaluation of the Evolution of Arterial and Microcirculatory Endothelial Function in Obese Patients With Type-2 Diabetes Versus Non-diabetic Obese Patients After a First Bariatric Surgery
Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03636243
What this study is about
The weight reduction obtained after a first bariatric surgery would improve the vascular (correction of endothelial dysfunction, improvement of arterial wall compliance and evolution of the atherothrombotic process) and microcirculatory function in obese patients with type-2 diabetes.
Basic eligibility
Full registry criteria
Treatments and study arms
Vascularly biological assessment
22.5 ml of blood will be collected at day -15, month 3 and month 12.
Analysis of vasomotor endothelial function
Evaluation of the peripheral endothelial function by digital tonometry using the 'EndoPATTM2000' system \[Itamar Medical Ltd., Caeserea, Israel\] before and after induction of post occlusive reactive hyperemia at day -15, month 3 and month 12.
Analysis of arterial compliance
Evaluation of the aortic pulse wave velocity in the aortofemoral segment or in the periphery (on the arm-ankle segment) by calculation of central aortic pressure (CAP) using the tonometric system 'Complior ™' \[Alam Medical, France\] at day -15, month 3 and month 12
Exploration of microcirculation
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
Venous Doppler Ultrasound
aneurysm screening at day -15, month 3 and month 12
Arterial pressure measurement
measurement of the systolic pressure at the toe using the SysToe™ device, and measurement of systolic and diastolic blood pressure using the Dinamap™ device at day -15, month 3 and month 12
Intima-Media Thickness measurement
Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
Exploration of neuropathy
non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
level of physical activity
pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
thoracic scanner
non-injected thoracic scanner visit at month 3
Primary outcomes
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Study locations
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