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

Active, not recruitingNot applicableInterventional

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionBariatric Surgery, Obese, Type2 Diabetes

Full registry criteria

Inclusion Criteria: * The patient is at least 18 years old and under 70 years old * The patient is available for a follow-up of 12 months * The patient signed the consent form * The patient must be affiliated or beneficiary to an health care plan * The patient is followed in hospital day care in the endocrine and metabolic disorders department at Nimes University Hospital for a first bariatric surgery Exclusion Criteria: * The subject participates in another interventional study. * The subject is in an exclusion period determined by a previous study. * The subject is under the protection of justice, guardianship or curatorship. * The subject refuses to sign the consent. * It is not possible to give the subject informed information. * The patient is pregnant or breastfeeding. * Subject with known advanced atherothrombotic disease (arterial disease of the lower limbs, significant carotid plaque (generating stenosis\> 50%), history of myocardial infarction, stroke) * The subject is type 1 diabetic. * The subject has already had a bariatric surgery.

Treatments and study arms

Vascularly biological assessment

Biological

22.5 ml of blood will be collected at day -15, month 3 and month 12.

Analysis of vasomotor endothelial function

Biological

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

Biological

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

Biological

The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12

Venous Doppler Ultrasound

Biological

aneurysm screening at day -15, month 3 and month 12

Arterial pressure measurement

Biological

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

Biological

Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12

Exploration of neuropathy

Biological

non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12

level of physical activity

Behavioral

pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12

thoracic scanner

Other

non-injected thoracic scanner visit at month 3

Primary outcomes

Reactive Hyperemia Index (RHI)day -15

Measured to the finger by tonometry using the "Endo-Pat 2000 device"

Reactive Hyperemia Index (RHI)Month 3

Measured to the finger by tonometry using the "Endo-Pat 2000 device"

Study locations

1 locations were listed when this page was built. The first 40 are shown.

CHU Nimes🇫🇷 Nîmes, France