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
NCT ID: NCT03636243
Last Updated: 2025-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
37 participants
INTERVENTIONAL
2019-10-15
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group of obese patients with type-2 diabetes
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
Group of non-diabetic obese patients
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
70 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Antonia PEREZ-MARTIN, Pr
Role: PRINCIPAL_INVESTIGATOR
Nîmes University Hospital
Locations
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CHU Nimes
Nîmes, , France
Countries
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Other Identifiers
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NIMAO/2017-02/APM-01
Identifier Type: -
Identifier Source: org_study_id
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