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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Bariatric Surgery, Obese, Type2 Diabetes

Intervention / Treatment
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* Biological: Vascularly biological assessment
* Biological: Analysis of vasomotor endothelial function
* Biological: Analysis of arterial compliance
* Biological: Exploration of microcirculation
* Biological: Venous Doppler Ultrasound
* Biological: Arterial pressure measurement
* Biological: Intima-Media Thickness measurement
* Biological: Exploration of neuropathy
* Behavioral: level of physical activity
* Other: thoracic scanner


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Group of obese patients with type-2 diabetes<br> | Biological: Vascularly biological assessment<br>* 22.5 ml of blood will be collected at day -15, month 3 and month 12.<br>Biological: Analysis of vasomotor endothelial function<br>* 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.<br>Biological: Analysis of arterial compliance<br>* 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<br>Biological: Exploration of microcirculation<br>* The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12<br>Biological: Venous Doppler Ultrasound<br>* aneurysm screening at day -15, month 3 and month 12<br>Biological: Arterial pressure measurement<br>* 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<br>Biological: Intima-Media Thickness measurement<br>* Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12<br>Biological: Exploration of neuropathy<br>* non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12<br>Behavioral: level of physical activity<br>* pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12<br>|
| Other: Group of non-diabetic obese patients<br> | Biological: Vascularly biological assessment<br>* 22.5 ml of blood will be collected at day -15, month 3 and month 12.<br>Biological: Analysis of vasomotor endothelial function<br>* 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.<br>Biological: Analysis of arterial compliance<br>* 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<br>Biological: Exploration of microcirculation<br>* The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12<br>Biological: Venous Doppler Ultrasound<br>* aneurysm screening at day -15, month 3 and month 12<br>Biological: Arterial pressure measurement<br>* 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<br>Biological: Intima-Media Thickness measurement<br>* Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12<br>Biological: Exploration of neuropathy<br>* non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12<br>Behavioral: level of physical activity<br>* pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12<br>Other: thoracic scanner<br>* non-injected thoracic scanner visit at month 3<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive Hyperemia Index (RHI) | Measured to the finger by tonometry using the Endo-Pat 2000 device | day -15 | 
| Reactive Hyperemia Index (RHI) | Measured to the finger by tonometry using the Endo-Pat 2000 device | Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactive Hyperemia Index (RHI) | reactive hyperemia index (%) | day -15, Month 12 | 
| Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups | pg/mL | day -15 | 
| Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups | pg/mL | Month 3 | 
| Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups | pg/mL | Month 12 | 
| Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups | pg/mL | Day -15 | 
| Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups | pg/mL | Month 3 | 
| Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups | pg/mL | Month 12 | 
| Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups | g/L | Day -15 | 
| Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups | g/L | Month 3 | 
| Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups | g/L | Month 12 | 
| Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups | ng/ml | Day -15 | 
| Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups | ng/ml | Month 3 | 
| Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups | ng/ml | Month 12 | 
| Evaluate the physical activity | number of steps in previous 4 days | Day -15 | 
| Evaluate the physical activity | number of steps in previous 4 days | Month 3 | 
| Evaluate the physical activity | number of steps in previous 4 days | Month 12 | 
| Creation of a biobank | storage of blood sample | Day -15 | 
| Creation of a biobank | storage of blood sample | Month 3 | 
| Creation of a biobank | storage of blood sample | Month 12 | 
| Compare toe pressure using the SysToe device in both groups and between groups | mmHg | Day -15 | 
| Compare toe pressure using the SysToe device in both groups and between groups | mmHg | Month 3 | 
| Compare toe pressure using the SysToe device in both groups and between groups | mmHg | Month 12 | 
| Compare the sweat function using the Sudoscan device in both groups and between groups | µV | Day -15 | 
| Compare the sweat function using the Sudoscan device in both groups and between groups | µV | Month 3 | 
| Compare the sweat function using the Sudoscan device in both groups and between groups | µV | Month 12 | 
| Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups | Hz | Day -15 | 
| Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups | Hz | Month 3 | 
| Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups | Hz | Month 12 | 
| Compare the sensitive conduction velocity in both groups and between groups | m/s | Day -15 | 
| Compare the sensitive conduction velocity in both groups and between groups | m/s | Month 3 | 
| Compare the sensitive conduction velocity in both groups and between groups | m/s | Month 12 | 
| Evaluate the presence of neuropathic pain using the questionnaire Neuropathic Pain in 4 Questions | If the score is greater than or equal to 4, the test is positive. | Day -15 | 
| Evaluate the presence of neuropathic pain using the questionnaire Neuropathic Pain in 4 Questions | If the score is greater than or equal to 4, the test is positive. | Month 3 | 
| Evaluate the presence of neuropathic pain using the questionnaire Neuropathic Pain in 4 Questions | If the score is greater than or equal to 4, the test is positive. | Month 12 | 
| Evaluate the quality of life using the Quality Of Life, Obesity and Dietetics questionnaire | It has 36 items, rated from 1 (always / enormously) to 5 (never / not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sex life - Q23-Q26, nutritional well-being - Q27-Q31 and diet experience - Q32-Q36). The rating of each dimension is reported at 100. The higher the score is close to 100, the better the quality of life related to this dimension. | Day -15 | 
| Evaluate the quality of life using the Quality Of Life, Obesity and Dietetics questionnaire | It has 36 items, rated from 1 (always / enormously) to 5 (never / not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sex life - Q23-Q26, nutritional well-being - Q27-Q31 and diet experience - Q32-Q36). The rating of each dimension is reported at 100. The higher the score is close to 100, the better the quality of life related to this dimension. | Month 3 | 
| Evaluate the quality of life using the Quality Of Life, Obesity and Dietetics questionnaire | It has 36 items, rated from 1 (always / enormously) to 5 (never / not at all). It explores five dimensions (physical impact - Q1-Q11, psychosocial impact - Q12-Q22, impact on sex life - Q23-Q26, nutritional well-being - Q27-Q31 and diet experience - Q32-Q36). The rating of each dimension is reported at 100. The higher the score is close to 100, the better the quality of life related to this dimension. | Month 12 | 
| Analysis of post-ischemic hyperemia using the laser doppler Perimed. |  | Day -15 | 
| Analysis of post-ischemic hyperemia using the laser doppler Perimed. |  | Month 3 | 
| Analysis of post-ischemic hyperemia using the laser doppler Perimed. |  | Month 12 | 
| Analysis of cutaneous vasomotion using the laser doppler Perimed. |  | Day -15 | 
| Analysis of cutaneous vasomotion using the laser doppler Perimed. |  | Month 3 | 
| Analysis of cutaneous vasomotion using the laser doppler Perimed. |  | Month 12 | 
| study of the peri-aortic and peri-brachial adipose tissue (TAPV) | comparison of peri-aortic and peri-brachial peri-vascular adipose tissue (PVAPT), before and 3 months after CB, in the group of 20 non-diabetic obese patients. Semi-automatic quantification with identification by the density of the pixels corresponding to the TA (-195 to -45 HU (Hounsfield Units) and 3D reconstruction for volumetric analysis | Month 3 |