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ACTIVE NOT RECRUITING
NCT03636243
NA

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

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

37

Start Date

2019-10-15

Completion Date

2025-09

Last Updated

2025-01-07

Healthy Volunteers

No

Interventions

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

Locations (1)

CHU Nimes

Nîmes, France