Bariatric Surgery, Obese, Type2 Diabetes
Conditions
Brief 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.
Interventions
BIOLOGICALVascularly biological assessment
22.5 ml of blood will be collected at day -15, month 3 and month 12.
BIOLOGICALAnalysis 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.
BIOLOGICALAnalysis 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
BIOLOGICALExploration of microcirculation
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
BIOLOGICALVenous Doppler Ultrasound
aneurysm screening at day -15, month 3 and month 12
BIOLOGICALArterial 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
BIOLOGICALIntima-Media Thickness measurement
Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
BIOLOGICALExploration of neuropathy
non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
BEHAVIORALlevel of physical activity
pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
OTHERthoracic scanner
non-injected thoracic scanner visit at month 3
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactive Hyperemia Index (RHI) | day -15 | Measured to the finger by tonometry using the Endo-Pat 2000 device |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups | day -15 | pg/mL |
| Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups | Day -15 | pg/mL |
| Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups | Day -15 | g/L |
| Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups | Day -15 | ng/ml |
| Evaluate the physical activity | Day -15 | number of steps in previous 4 days |
| Creation of a biobank | Day -15 | storage of blood sample |
| Compare toe pressure using the SysToe device in both groups and between groups | Day -15 | mmHg |
| Reactive Hyperemia Index (RHI) | day -15, Month 12 | reactive hyperemia index (%) |
| Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups | Day -15 | Hz |
| Compare the sensitive conduction velocity in both groups and between groups | Day -15 | m/s |
| Evaluate the presence of neuropathic pain using the questionnaire Neuropathic Pain in 4 Questions | Day -15 | If the score is greater than or equal to 4, the test is positive. |
| Evaluate the quality of life using the Quality Of Life, Obesity and Dietetics questionnaire | Day -15 | 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. |
| Analysis of post-ischemic hyperemia using the laser doppler Perimed. | Day -15 | — |
| Analysis of cutaneous vasomotion using the laser doppler Perimed. | Day -15 | — |
| study of the peri-aortic and peri-brachial adipose tissue (TAPV) | Month 3 | 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 |
| Compare the sweat function using the Sudoscan device in both groups and between groups | Day -15 | µV |
Countries
France
Outcome results
None listed