Back to resultsComparative 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 (BariVaDia)
Primary Purpose
Bariatric Surgery, Obese, Type2 Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vascularly biological assessment
Analysis of vasomotor endothelial function
Analysis of arterial compliance
Exploration of microcirculation
Venous Doppler Ultrasound
Arterial pressure measurement
Intima-Media Thickness measurement
Exploration of neuropathy
level of physical activity
thoracic scanner
Sponsored by
About this trial
This is an interventional other trial for Bariatric Surgery
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.
Sites / Locations
- CHU NimesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Group of obese patients with type-2 diabetes
Group of non-diabetic obese patients
Arm Description
Outcomes
Primary Outcome Measures
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Secondary Outcome Measures
Reactive Hyperemia Index (RHI)
reactive hyperemia index (%)
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
pg/mL
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Evaluate the physical activity
number of steps in previous 4 days
Evaluate the physical activity
number of steps in previous 4 days
Evaluate the physical activity
number of steps in previous 4 days
Creation of a biobank
storage of blood sample
Creation of a biobank
storage of blood sample
Creation of a biobank
storage of blood sample
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Compare the sweat function using the" Sudoscan" device in both groups and between groups
µV
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Compare the sensitive conduction velocity in both groups and between groups
m/s
Compare the sensitive conduction velocity in both groups and between groups
m/s
Compare the sensitive conduction velocity in both groups and between groups
m/s
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.
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.
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.
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.
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.
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.
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Analysis of cutaneous vasomotion using the laser doppler Perimed.
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
Full Information
NCT ID
NCT03636243
First Posted
August 16, 2018
Last Updated
March 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nīmes
1. Study Identification
Unique Protocol Identification Number
NCT03636243
Brief 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
Acronym
BariVaDia
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
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nīmes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Obese, Type2 Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group of obese patients with type-2 diabetes
Arm Type
Other
Arm Title
Group of non-diabetic obese patients
Arm Type
Other
Intervention Type
Biological
Intervention Name(s)
Vascularly biological assessment
Intervention Description
22.5 ml of blood will be collected at day -15, month 3 and month 12.
Intervention Type
Biological
Intervention Name(s)
Analysis of vasomotor endothelial function
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Analysis of arterial compliance
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Exploration of microcirculation
Intervention Description
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
Intervention Type
Biological
Intervention Name(s)
Venous Doppler Ultrasound
Intervention Description
aneurysm screening at day -15, month 3 and month 12
Intervention Type
Biological
Intervention Name(s)
Arterial pressure measurement
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Intima-Media Thickness measurement
Intervention Description
Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
Intervention Type
Biological
Intervention Name(s)
Exploration of neuropathy
Intervention Description
non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
Intervention Type
Behavioral
Intervention Name(s)
level of physical activity
Intervention Description
pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
Intervention Type
Other
Intervention Name(s)
thoracic scanner
Intervention Description
non-injected thoracic scanner visit at month 3
Primary Outcome Measure Information:
Title
Reactive Hyperemia Index (RHI)
Description
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Time Frame
day -15
Title
Reactive Hyperemia Index (RHI)
Description
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Time Frame
Month 3
Secondary Outcome Measure Information:
Title
Reactive Hyperemia Index (RHI)
Description
reactive hyperemia index (%)
Time Frame
day -15, Month 12
Title
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
day -15
Title
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
Month 3
Title
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
Month 12
Title
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
Day -15
Title
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
Month 3
Title
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups
Description
pg/mL
Time Frame
Month 12
Title
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Description
g/L
Time Frame
Day -15
Title
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Description
g/L
Time Frame
Month 3
Title
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Description
g/L
Time Frame
Month 12
Title
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Description
ng/ml
Time Frame
Day -15
Title
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Description
ng/ml
Time Frame
Month 3
Title
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Description
ng/ml
Time Frame
Month 12
Title
Evaluate the physical activity
Description
number of steps in previous 4 days
Time Frame
Day -15
Title
Evaluate the physical activity
Description
number of steps in previous 4 days
Time Frame
Month 3
Title
Evaluate the physical activity
Description
number of steps in previous 4 days
Time Frame
Month 12
Title
Creation of a biobank
Description
storage of blood sample
Time Frame
Day -15
Title
Creation of a biobank
Description
storage of blood sample
Time Frame
Month 3
Title
Creation of a biobank
Description
storage of blood sample
Time Frame
Month 12
Title
Compare toe pressure using the SysToe device in both groups and between groups
Description
mmHg
Time Frame
Day -15
Title
Compare toe pressure using the SysToe device in both groups and between groups
Description
mmHg
Time Frame
Month 3
Title
Compare toe pressure using the SysToe device in both groups and between groups
Description
mmHg
Time Frame
Month 12
Title
Compare the sweat function using the" Sudoscan" device in both groups and between groups
Description
µV
Time Frame
Day -15
Title
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Description
µV
Time Frame
Month 3
Title
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Description
µV
Time Frame
Month 12
Title
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Description
Hz
Time Frame
Day -15
Title
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Description
Hz
Time Frame
Month 3
Title
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Description
Hz
Time Frame
Month 12
Title
Compare the sensitive conduction velocity in both groups and between groups
Description
m/s
Time Frame
Day -15
Title
Compare the sensitive conduction velocity in both groups and between groups
Description
m/s
Time Frame
Month 3
Title
Compare the sensitive conduction velocity in both groups and between groups
Description
m/s
Time Frame
Month 12
Title
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Description
If the score is greater than or equal to 4, the test is positive.
Time Frame
Day -15
Title
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Description
If the score is greater than or equal to 4, the test is positive.
Time Frame
Month 3
Title
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Description
If the score is greater than or equal to 4, the test is positive.
Time Frame
Month 12
Title
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Description
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
Title
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Description
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
Title
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Description
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
Title
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame
Day -15
Title
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame
Month 3
Title
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame
Month 12
Title
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame
Day -15
Title
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame
Month 3
Title
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame
Month 12
Title
study of the peri-aortic and peri-brachial adipose tissue (TAPV)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Antonia PEREZ-MARTIN, Pr
Phone
+33(0)4.66.68.33.13
Email
antonia.perez.martin@chu-nimes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonia PEREZ-MARTIN, Pr
Organizational Affiliation
Nîmes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Nimes
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anissa Megzari
Phone
04.66.68.30.52
Email
drc@chu-nimes.fr
First Name & Middle Initial & Last Name & Degree
Anne-Marie Guedj, MD
First Name & Middle Initial & Last Name & Degree
Véronique TAILLARD, MD
First Name & Middle Initial & Last Name & Degree
Jean-Christophe GRIS, MD
First Name & Middle Initial & Last Name & Degree
Sylvie BOUVIER, MD
First Name & Middle Initial & Last Name & Degree
Ion DONICI, MD
First Name & Middle Initial & Last Name & Degree
Michel PRUDHOMME, MD
First Name & Middle Initial & Last Name & Degree
Isabelle AICHOUN, MD
First Name & Middle Initial & Last Name & Degree
Sarah COUDRAY, MD
First Name & Middle Initial & Last Name & Degree
Jérémy LAURENT, MD
12. IPD Sharing Statement
Learn more about this trial
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
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