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

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

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes

  lead OTHER

Principal Investigators

• Antonia PEREZ-MARTIN, Pr · Nîmes University Hospital

Study Design

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-10-15

Primary Completion

2025-09-30

Completion

2025-09-30

Countries

• France

Study Locations