Clinical trial NCT03636243: 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
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Obese
Type2 Diabetes
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2018-08-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Reactive Hyperemia Index (RHI)
timeFrame: day -15
measure: Reactive Hyperemia Index (RHI)
timeFrame: Month 3
Secondary outcomes:
measure: Reactive Hyperemia Index (RHI)
timeFrame: day -15, Month 12
measure: Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
timeFrame: day -15
measure: Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
timeFrame: Month 3
measure: Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
timeFrame: Month 12
measure: Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
timeFrame: Day -15
measure: Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
timeFrame: Month 3
measure: Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
timeFrame: Month 12
measure: Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
timeFrame: Day -15
measure: Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
timeFrame: Month 3
measure: Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
timeFrame: Month 12
measure: Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
timeFrame: Day -15
measure: Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
timeFrame: Month 3
measure: Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
timeFrame: Month 12
measure: Evaluate the physical activity
timeFrame: Day -15
measure: Evaluate the physical activity
timeFrame: Month 3
measure: Evaluate the physical activity
timeFrame: Month 12
measure: Creation of a biobank
timeFrame: Day -15
measure: Creation of a biobank
timeFrame: Month 3
measure: Creation of a biobank
timeFrame: Month 12
measure: Compare toe pressure using the SysToe device in both groups and between groups
timeFrame: Day -15
measure: Compare toe pressure using the SysToe device in both groups and between groups
timeFrame: Month 3
measure: Compare toe pressure using the SysToe device in both groups and between groups
timeFrame: Month 12
measure: Compare the sweat function using the" Sudoscan" device in both groups and between groups
timeFrame: Day -15
measure: Compare the sweat function using the "Sudoscan" device in both groups and between groups
timeFrame: Month 3
measure: Compare the sweat function using the "Sudoscan" device in both groups and between groups
timeFrame: Month 12
measure: Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
timeFrame: Day -15
measure: Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
timeFrame: Month 3
measure: Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
timeFrame: Month 12
measure: Compare the sensitive conduction velocity in both groups and between groups
timeFrame: Day -15
measure: Compare the sensitive conduction velocity in both groups and between groups
timeFrame: Month 3
measure: Compare the sensitive conduction velocity in both groups and between groups
timeFrame: Month 12
measure: Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
timeFrame: Day -15
measure: Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
timeFrame: Month 3
measure: Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
timeFrame: Month 12
measure: Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
timeFrame: Day -15
measure: Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
timeFrame: Month 3
measure: Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
timeFrame: Month 12
measure: Analysis of post-ischemic hyperemia using the laser doppler Perimed.
timeFrame: Day -15
measure: Analysis of post-ischemic hyperemia using the laser doppler Perimed.
timeFrame: Month 3
measure: Analysis of post-ischemic hyperemia using the laser doppler Perimed.
timeFrame: Month 12
measure: Analysis of cutaneous vasomotion using the laser doppler Perimed.
timeFrame: Day -15
measure: Analysis of cutaneous vasomotion using the laser doppler Perimed.
timeFrame: Month 3
measure: Analysis of cutaneous vasomotion using the laser doppler Perimed.
timeFrame: Month 12
measure: study of the peri-aortic and peri-brachial adipose tissue (TAPV)
timeFrame: Month 3
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU Nimes
Study officials:
affiliation: Nîmes University Hospital
name: Antonia PEREZ-MARTIN, Pr
role: PRINCIPAL_INVESTIGATOR
References: