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NCT Number: 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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Bariatric Surgery Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Type2 Diabetes

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nimes

Nîmes, 30029, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vascularly biological assessment

Biological

22.5 ml of blood will be collected at day -15, month 3 and month 12.

Analysis of vasomotor endothelial function

Biological

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

Biological

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

Biological

The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12

Venous Doppler Ultrasound

Biological

aneurysm screening at day -15, month 3 and month 12

Arterial pressure measurement

Biological

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

Biological

Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12

Exploration of neuropathy

Biological

non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12

level of physical activity

Behavioral

pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12

thoracic scanner

Other

non-injected thoracic scanner visit at month 3

Primary outcomes

  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 outcomes

  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

  44. study of the peri-aortic and peri-brachial adipose tissue (TAPV)

    Time frame: Month 3

    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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: BariVaDia

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Aug 17, 2018
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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