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)

• ClinicalTrials.gov Identifier: NCT03636243
• Recruitment Status: Recruiting
• First Posted: August 17, 2018
• Last Update Posted: August 4, 2021
• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Information provided by (Responsible Party): Centre Hospitalier Universitaire de Nīmes

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.

Condition or disease	Intervention/treatment	Phase
Bariatric Surgery; Obese; Type2 Diabetes	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	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 80 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Actual Study Start Date: October 15, 2019
• Estimated Primary Completion Date: January 2022
• Estimated Study Completion Date: January 2022

Arms and Interventions

Arm	Intervention/treatment
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
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

Outcome Measures

Primary Outcome Measures :

1. Reactive Hyperemia Index (RHI) [ Time Frame: day -15 ]
   Measured to the finger by tonometry using the "Endo-Pat 2000 device"
2. Reactive Hyperemia Index (RHI) [ Time Frame: Month 3 ]
   Measured to the finger by tonometry using the "Endo-Pat 2000 device"

Secondary Outcome Measures :

1. Reactive Hyperemia Index (RHI) [ Time Frame: day -15, Month 12 ]
   reactive hyperemia index (%)
2. Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups [ Time Frame: day -15 ]
   pg/mL
3. Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups [ Time Frame: Month 3 ]
   pg/mL
4. Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups [ Time Frame: Month 12 ]
   pg/mL
5. Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups [ Time Frame: Day -15 ]
   pg/mL
6. Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups [ Time Frame: Month 3 ]
   pg/mL
7. Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups [ Time Frame: Month 12 ]
   pg/mL
8. Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups [ Time Frame: Day -15 ]
   g/L
9. Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups [ Time Frame: Month 3 ]
   g/L
10. Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups [ Time Frame: Month 12 ]
    g/L
11. Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups [ Time Frame: Day -15 ]
    ng/ml
12. Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups [ Time Frame: Month 3 ]
    ng/ml
13. Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups [ Time Frame: Month 12 ]
    ng/ml
14. Evaluate the physical activity [ Time Frame: Day -15 ]
    number of steps in previous 4 days
15. Evaluate the physical activity [ Time Frame: Month 3 ]
    number of steps in previous 4 days
16. Evaluate the physical activity [ Time Frame: Month 12 ]
    number of steps in previous 4 days
17. Creation of a biobank [ Time Frame: Day -15 ]
    storage of blood sample
18. Creation of a biobank [ Time Frame: Month 3 ]
    storage of blood sample
19. Creation of a biobank [ Time Frame: Month 12 ]
    storage of blood sample
20. Compare toe pressure using the SysToe device in both groups and between groups [ Time Frame: Day -15 ]
    mmHg
21. Compare toe pressure using the SysToe device in both groups and between groups [ Time Frame: Month 3 ]
    mmHg
22. Compare toe pressure using the SysToe device in both groups and between groups [ Time Frame: Month 12 ]
    mmHg
23. Compare the sweat function using the" Sudoscan" device in both groups and between groups [ Time Frame: Day -15 ]
    µV
24. Compare the sweat function using the "Sudoscan" device in both groups and between groups [ Time Frame: Month 3 ]
    µV
25. Compare the sweat function using the "Sudoscan" device in both groups and between groups [ Time Frame: Month 12 ]
    µV
26. Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups [ Time Frame: Day -15 ]
    Hz
27. Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups [ Time Frame: Month 3 ]
    Hz
28. Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups [ Time Frame: Month 12 ]
    Hz
29. Compare the sensitive conduction velocity in both groups and between groups [ Time Frame: Day -15 ]
    m/s
30. Compare the sensitive conduction velocity in both groups and between groups [ Time Frame: Month 3 ]
    m/s
31. Compare the sensitive conduction velocity in both groups and between groups [ Time Frame: Month 12 ]
    m/s
32. Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions" [ Time Frame: Day -15 ]
    If the score is greater than or equal to 4, the test is positive.
33. Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions" [ Time Frame: Month 3 ]
    If the score is greater than or equal to 4, the test is positive.
34. Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions" [ Time Frame: Month 12 ]
    If the score is greater than or equal to 4, the test is positive.
35. Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire [ Time Frame: Day -15 ]
    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.
36. Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire [ Time Frame: Month 3 ]
    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.
37. Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire [ Time Frame: Month 12 ]
    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.
38. Analysis of post-ischemic hyperemia using the laser doppler Perimed. [ Time Frame: Day -15 ]
39. Analysis of post-ischemic hyperemia using the laser doppler Perimed. [ Time Frame: Month 3 ]
40. Analysis of post-ischemic hyperemia using the laser doppler Perimed. [ Time Frame: Month 12 ]
41. Analysis of cutaneous vasomotion using the laser doppler Perimed. [ Time Frame: Day -15 ]
42. Analysis of cutaneous vasomotion using the laser doppler Perimed. [ Time Frame: Month 3 ]
43. Analysis of cutaneous vasomotion using the laser doppler Perimed. [ Time Frame: Month 12 ]

Eligibility Criteria

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

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.

Contacts and Locations

Contacts

Contact: Antonia PEREZ-MARTIN, Pr; +33(0)4.66.68.33.13; antonia.perez.martin@chu-nimes.fr

Locations

France

CHU Nimes; Recruiting

Nîmes, France, 30029

Contact: Anissa Megzari 04.66.68.30.52 drc@chu-nimes.fr

Sub-Investigator: Anne-Marie Guedj, MD

Sub-Investigator: Véronique TAILLARD, MD

Sub-Investigator: Jean-Christophe GRIS, MD

Sub-Investigator: Sylvie BOUVIER, MD

Sub-Investigator: Ion DONICI, MD

Sub-Investigator: Michel PRUDHOMME, MD

Sub-Investigator: Isabelle AICHOUN, MD

Sub-Investigator: Sarah COUDRAY, MD

Sub-Investigator: Jérémy LAURENT, MD

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nīmes

Investigators

• Principal Investigator: Antonia PEREZ-MARTIN, Pr; Nîmes University Hospital

More Information

• Responsible Party: Centre Hospitalier Universitaire de Nīmes
• ClinicalTrials.gov Identifier: NCT03636243
• Other Study ID Numbers: NIMAO/2017-02/APM-01
• First Posted: August 17, 2018
• Last Update Posted: August 4, 2021
• Last Verified: August 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases