NCT03636243

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Bariatric Surgery
• Obese
• Type2 Diabetes

Interventions

Type	Name	Description
BIOLOGICAL	Vascularly biological assessment	22.5 ml of blood will be collected at day -15, month 3 and month 12.
BIOLOGICAL	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.
BIOLOGICAL	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
BIOLOGICAL	Exploration of microcirculation	The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
BIOLOGICAL	Venous Doppler Ultrasound	aneurysm screening at day -15, month 3 and month 12
BIOLOGICAL	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
BIOLOGICAL	Intima-Media Thickness measurement	Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
BIOLOGICAL	Exploration of neuropathy	non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
BEHAVIORAL	level of physical activity	pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
OTHER	thoracic scanner	non-injected thoracic scanner visit at month 3

Timeline

• Start date: 2019-10-15
• Primary completion: 2025-09-01
• Completion: 2025-09-01
• First posted: 2018-08-17
• Last updated: 2025-01-07

Locations

1 site across 1 country: France