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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of obese patients with type-2 diabetes | Other |
| |
| Group of non-diabetic obese patients | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vascularly biological assessment | Biological | 22.5 ml of blood will be collected at day -15, month 3 and month 12. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia PEREZ-MARTIN, Pr | Nîmes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nimes | Nîmes | 30029 | France |
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| 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 |
|
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 |
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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