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

Type2 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03636243
• Other study ID #: NIMAO/2017-02/APM-01
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: September 2025

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Antonia PEREZ-MARTIN, Pr
• Phone: +33(0)4.66.68.33.13
• Email: antonia.perez.martin[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: September 2025
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Obese
• Type2 Diabetes

Intervention

Biological:
• Vascularly biological assessment
22.5 ml of blood will be collected at day -15, month 3 and month 12.
• 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.
• 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
• Exploration of microcirculation
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
• Venous Doppler Ultrasound
aneurysm screening at day -15, month 3 and month 12
• 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
• Intima-Media Thickness measurement
Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
• 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

Locations

Country	Name	City	State
France	CHU Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactive Hyperemia Index (RHI)	Measured to the finger by tonometry using the "Endo-Pat 2000 device"	day -15
Primary	Reactive Hyperemia Index (RHI)	Measured to the finger by tonometry using the "Endo-Pat 2000 device"	Month 3
Secondary	Reactive Hyperemia Index (RHI)	reactive hyperemia index (%)	day -15, Month 12
Secondary	Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups	pg/mL	day -15
Secondary	Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups	pg/mL	Month 3
Secondary	Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups	pg/mL	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups	g/L	Day -15
Secondary	Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups	g/L	Month 3
Secondary	Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups	g/L	Month 12
Secondary	Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups	ng/ml	Day -15
Secondary	Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups	ng/ml	Month 3
Secondary	Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups	ng/ml	Month 12
Secondary	Evaluate the physical activity	number of steps in previous 4 days	Day -15
Secondary	Evaluate the physical activity	number of steps in previous 4 days	Month 3
Secondary	Evaluate the physical activity	number of steps in previous 4 days	Month 12
Secondary	Creation of a biobank	storage of blood sample	Day -15
Secondary	Creation of a biobank	storage of blood sample	Month 3
Secondary	Creation of a biobank	storage of blood sample	Month 12
Secondary	Compare toe pressure using the SysToe device in both groups and between groups	mmHg	Day -15
Secondary	Compare toe pressure using the SysToe device in both groups and between groups	mmHg	Month 3
Secondary	Compare toe pressure using the SysToe device in both groups and between groups	mmHg	Month 12
Secondary	Compare the sweat function using the" Sudoscan" device in both groups and between groups	µV	Day -15
Secondary	Compare the sweat function using the "Sudoscan" device in both groups and between groups	µV	Month 3
Secondary	Compare the sweat function using the "Sudoscan" device in both groups and between groups	µV	Month 12
Secondary	Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups	Hz	Day -15
Secondary	Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups	Hz	Month 3
Secondary	Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups	Hz	Month 12
Secondary	Compare the sensitive conduction velocity in both groups and between groups	m/s	Day -15
Secondary	Compare the sensitive conduction velocity in both groups and between groups	m/s	Month 3
Secondary	Compare the sensitive conduction velocity in both groups and between groups	m/s	Month 12
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Analysis of post-ischemic hyperemia using the laser doppler Perimed.		Day -15
Secondary	Analysis of post-ischemic hyperemia using the laser doppler Perimed.		Month 3
Secondary	Analysis of post-ischemic hyperemia using the laser doppler Perimed.		Month 12
Secondary	Analysis of cutaneous vasomotion using the laser doppler Perimed.		Day -15
Secondary	Analysis of cutaneous vasomotion using the laser doppler Perimed.		Month 3
Secondary	Analysis of cutaneous vasomotion using the laser doppler Perimed.		Month 12
Secondary	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