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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
37
22.5 ml of blood will be collected at day -15, month 3 and month 12.
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.
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
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
aneurysm screening at day -15, month 3 and month 12
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 using an ultrasound machine at day -15, month 3 and month 12
non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
non-injected thoracic scanner visit at month 3
CHU Nimes
Nîmes, France
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Time frame: day -15
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Time frame: Month 3
Reactive Hyperemia Index (RHI)
reactive hyperemia index (%)
Time frame: 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
Time frame: day -15
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Time frame: Month 3
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 12
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Time frame: Day -15
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Time frame: Month 3
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Time frame: Month 12
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Time frame: Day -15
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Time frame: Month 3
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Time frame: Month 12
Evaluate the physical activity
number of steps in previous 4 days
Time frame: Day -15
Evaluate the physical activity
number of steps in previous 4 days
Time frame: Month 3
Evaluate the physical activity
number of steps in previous 4 days
Time frame: Month 12
Creation of a biobank
storage of blood sample
Time frame: Day -15
Creation of a biobank
storage of blood sample
Time frame: Month 3
Creation of a biobank
storage of blood sample
Time frame: Month 12
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Time frame: Day -15
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Time frame: Month 3
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Time frame: Month 12
Compare the sweat function using the" Sudoscan" device in both groups and between groups
µV
Time frame: Day -15
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Time frame: Month 3
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Time frame: Month 12
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Time frame: Day -15
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Time frame: Month 3
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Time frame: Month 12
Compare the sensitive conduction velocity in both groups and between groups
m/s
Time frame: Day -15
Compare the sensitive conduction velocity in both groups and between groups
m/s
Time frame: Month 3
Compare the sensitive conduction velocity in both groups and between groups
m/s
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 12
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Day -15
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Month 3
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Month 12
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time frame: Day -15
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time frame: Month 3
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time frame: 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
Time frame: Month 3
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