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 (BariVaDia)

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 Overview

• Status: Recruiting
• Conditions: Type2 Diabetes; Obese; Bariatric Surgery
• Intervention / Treatment: Biological: Vascularly biological assessment; Biological: Analysis of vasomotor endothelial function; Biological: Analysis of arterial compliance; Biological: Exploration of microcirculation; Biological: Venous Doppler Ultrasound; Biological: Arterial pressure measurement; Biological: Intima-Media Thickness measurement; Biological: Exploration of neuropathy; Behavioral: level of physical activity; Other: thoracic scanner

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Antonia PEREZ-MARTIN, Pr; Phone Number: +33(0)4.66.68.33.13; Email: antonia.perez.martin@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • Chu Nimes
    • Sub-Investigator: Anne-Marie Guedj, MD
    • Contact: Anissa Megzari; Phone Number: 04.66.68.30.52; Email: drc@chu-nimes.fr
    • Sub-Investigator: Véronique TAILLARD, MD
    • Sub-Investigator: Jean-Christophe GRIS, MD
    • Sub-Investigator: Sylvie BOUVIER, MD
    • Sub-Investigator: Ion DONICI, MD
    • Sub-Investigator: Isabelle AICHOUN, MD
    • Sub-Investigator: Sarah COUDRAY, MD
    • Sub-Investigator: Jérémy LAURENT, MD
    • Sub-Investigator: Michel PRUDHOMME, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Group of obese patients with type-2 diabetes	Biological: Vascularly biological assessment; 22.5 ml of blood will be collected at day -15, month 3 and month 12.; Biological: Analysis 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.; Biological: Analysis 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; Biological: Exploration of microcirculation; The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12; Biological: Venous Doppler Ultrasound; aneurysm screening at day -15, month 3 and month 12; Biological: Arterial 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; Biological: Intima-Media Thickness measurement; Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12; Biological: Exploration of neuropathy; non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12; Behavioral: level of physical activity; pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
Other: Group of non-diabetic obese patients	Biological: Vascularly biological assessment; 22.5 ml of blood will be collected at day -15, month 3 and month 12.; Biological: Analysis 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.; Biological: Analysis 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; Biological: Exploration of microcirculation; The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12; Biological: Venous Doppler Ultrasound; aneurysm screening at day -15, month 3 and month 12; Biological: Arterial 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; Biological: Intima-Media Thickness measurement; Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12; Biological: Exploration of neuropathy; non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12; Behavioral: level of physical activity; pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12; Other: thoracic scanner; non-injected thoracic scanner visit at month 3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Antonia PEREZ-MARTIN, Pr, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: NIMAO/2017-02/APM-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No