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)

January 6, 2025 updated by: Centre Hospitalier Universitaire de Nīmes
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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
37

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • France
      • Nîmes, France, 30029
        • CHU Nîmes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reactive Hyperemia Index (RHI)
Time Frame: day -15
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
day -15
Reactive Hyperemia Index (RHI)
Time Frame: Month 3
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Month 3

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reactive Hyperemia Index (RHI)
Time Frame: day -15, Month 12
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
Time Frame: day -15
pg/mL
day -15
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
Month 3
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
Month 12
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
Day -15
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
Month 3
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
Month 12
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time Frame: Day -15
g/L
Day -15
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time Frame: Month 3
g/L
Month 3
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time Frame: Month 12
g/L
Month 12
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time Frame: Day -15
ng/ml
Day -15
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time Frame: Month 3
ng/ml
Month 3
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time Frame: Month 12
ng/ml
Month 12
Evaluate the physical activity
Time Frame: Day -15
number of steps in previous 4 days
Day -15
Evaluate the physical activity
Time Frame: Month 3
number of steps in previous 4 days
Month 3
Evaluate the physical activity
Time Frame: Month 12
number of steps in previous 4 days
Month 12
Creation of a biobank
Time Frame: Day -15
storage of blood sample
Day -15
Creation of a biobank
Time Frame: Month 3
storage of blood sample
Month 3
Creation of a biobank
Time Frame: Month 12
storage of blood sample
Month 12
Compare toe pressure using the SysToe device in both groups and between groups
Time Frame: Day -15
mmHg
Day -15
Compare toe pressure using the SysToe device in both groups and between groups
Time Frame: Month 3
mmHg
Month 3
Compare toe pressure using the SysToe device in both groups and between groups
Time Frame: Month 12
mmHg
Month 12
Compare the sweat function using the" Sudoscan" device in both groups and between groups
Time Frame: Day -15
µV
Day -15
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Time Frame: Month 3
µV
Month 3
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Time Frame: Month 12
µV
Month 12
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time Frame: Day -15
Hz
Day -15
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time Frame: Month 3
Hz
Month 3
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time Frame: Month 12
Hz
Month 12
Compare the sensitive conduction velocity in both groups and between groups
Time Frame: Day -15
m/s
Day -15
Compare the sensitive conduction velocity in both groups and between groups
Time Frame: Month 3
m/s
Month 3
Compare the sensitive conduction velocity in both groups and between groups
Time Frame: Month 12
m/s
Month 12
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.
Day -15
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.
Month 3
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.
Month 12
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.
Day -15
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.
Month 3
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.
Month 12
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame: Day -15
Day -15
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame: Month 3
Month 3
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time Frame: Month 12
Month 12
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame: Day -15
Day -15
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame: Month 3
Month 3
Analysis of cutaneous vasomotion using the laser doppler Perimed.
Time Frame: Month 12
Month 12
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
Month 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire de Nīmes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Antonia PEREZ-MARTIN, Pr, Nîmes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 17, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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