Bariatric SurgeryBariVaDiaNCT03636243
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
A study testing Vascularly biological assessment, Analysis of vasomotor endothelial function and Analysis of arterial compliance in people with Bariatric Surgery and Obese, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bariatric Surgery, Obese, Type2 Diabetes
- What is being tested?
- Vascularly biological assessment, Analysis of vasomotor endothelial function and Analysis of arterial compliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteFrance
- Study dates
- 15 Oct 2019to 9 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Bariatric Surgery, Obese, Type2 Diabetes
- Being tested
- Vascularly biological assessment, Analysis of vasomotor endothelial function, Analysis of arterial compliance, Exploration of microcirculation, Venous Doppler Ultrasound
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascularly biological assessmentBiological
22.5 ml of blood will be collected at day -15, month 3 and month 12.
Analysis of vasomotor endothelial functionBiological
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 complianceBiological
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 microcirculationBiological
The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
Venous Doppler UltrasoundBiological
aneurysm screening at day -15, month 3 and month 12
Arterial pressure measurementBiological
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 measurementBiological
Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
Exploration of neuropathyBiological
non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
level of physical activityBehavioural
pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
thoracic scannerOther
non-injected thoracic scanner visit at month 3
| Study group | Role | What they receive |
|---|---|---|
| Group of obese patients with type-2 diabetes | Other | Not described Receives: 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 |
| Group of non-diabetic obese patients | Other | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Measured: day -15
Reactive Hyperemia Index (RHI)
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Measured: Month 3
Secondary outcomes (44)
Reactive Hyperemia Index (RHI)
reactive hyperemia index (%)
Measured: 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
Measured: day -15
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Measured: Month 3
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
pg/mL
Measured: 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
Measured: 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
Measured: 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
Measured: Month 12
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Measured: Day -15
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Measured: Month 3
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
g/L
Measured: Month 12
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Measured: Day -15
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Measured: Month 3
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
ng/ml
Measured: Month 12
Evaluate the physical activity
number of steps in previous 4 days
Measured: Day -15
Evaluate the physical activity
number of steps in previous 4 days
Measured: Month 3
Evaluate the physical activity
number of steps in previous 4 days
Measured: Month 12
Creation of a biobank
storage of blood sample
Measured: Day -15
Creation of a biobank
storage of blood sample
Measured: Month 3
Creation of a biobank
storage of blood sample
Measured: Month 12
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Measured: Day -15
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Measured: Month 3
Compare toe pressure using the SysToe device in both groups and between groups
mmHg
Measured: Month 12
Compare the sweat function using the" Sudoscan" device in both groups and between groups
µV
Measured: Day -15
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Measured: Month 3
Compare the sweat function using the "Sudoscan" device in both groups and between groups
µV
Measured: Month 12
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Measured: Day -15
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Measured: Month 3
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Hz
Measured: Month 12
Compare the sensitive conduction velocity in both groups and between groups
m/s
Measured: Day -15
Compare the sensitive conduction velocity in both groups and between groups
m/s
Measured: Month 3
Compare the sensitive conduction velocity in both groups and between groups
m/s
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Month 12
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
%
Measured: Day -15
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
%
Measured: Month 3
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
%
Measured: Month 12
Analysis of cutaneous vasomotion using the laser doppler Perimed.
%
Measured: Day -15
Analysis of cutaneous vasomotion using the laser doppler Perimed.
%
Measured: Month 3
Analysis of cutaneous vasomotion using the laser doppler Perimed.
%
Measured: 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
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start15 Oct 2019
- Primary completion9 Aug 2025
- Study completion9 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonia PEREZ-MARTIN, Pr, Principal investigator, Nîmes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03636243
- Sponsor's protocol ID
- NIMAO/2017-02/APM-01
- Acronym
- BariVaDia
- Status last verified
- Oct 2026
- First submitted
- 16 Aug 2018
- Last updated
- 22 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03636243
- Acronym / sponsor ID
- BariVaDia / NIMAO/2017-02/APM-01
- Conditions
- Bariatric Surgery, Obese, Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 9 Aug 2025 (actual)
- Study completion
- 9 Aug 2025 (actual)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of obese patients with type-2 diabetes | Other | 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 |
| Group of non-diabetic obese patients | Other | 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascularly biological assessment22.5 ml of blood will be collected at day -15, month 3 and month 12. | Biological | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Analysis of vasomotor endothelial functionEvaluation 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 | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Analysis of arterial complianceEvaluation 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 | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Exploration of microcirculationThe microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12 | Biological | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Venous Doppler Ultrasoundaneurysm screening at day -15, month 3 and month 12 | Biological | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Arterial pressure measurementmeasurement 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 | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Intima-Media Thickness measurementIntima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12 | Biological | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| Exploration of neuropathynon-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12 | Biological | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| level of physical activitypedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12 | Behavioural | Group of non-diabetic obese patients, Group of obese patients with type-2 diabetes |
| thoracic scannernon-injected thoracic scanner visit at month 3 | Other | Group of non-diabetic obese patients |
Primary outcome
Reactive Hyperemia Index (RHI)
Time frame: day -15
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
Reactive Hyperemia Index (RHI)
Time frame: Month 3
Measured to the finger by tonometry using the "Endo-Pat 2000 device"
44 secondary outcomes
Reactive Hyperemia Index (RHI)
Time frame: 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
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups
Time frame: 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
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
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
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
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time frame: Day -15
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time frame: Month 3
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups
Time frame: Month 12
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time frame: Day -15
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time frame: Month 3
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups
Time frame: Month 12
Evaluate the physical activity
Time frame: Day -15
Evaluate the physical activity
Time frame: Month 3
Evaluate the physical activity
Time frame: Month 12
Creation of a biobank
Time frame: Day -15
Creation of a biobank
Time frame: Month 3
Creation of a biobank
Time frame: Month 12
Compare toe pressure using the SysToe device in both groups and between groups
Time frame: Day -15
Compare toe pressure using the SysToe device in both groups and between groups
Time frame: Month 3
Compare toe pressure using the SysToe device in both groups and between groups
Time frame: Month 12
Compare the sweat function using the" Sudoscan" device in both groups and between groups
Time frame: Day -15
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Time frame: Month 3
Compare the sweat function using the "Sudoscan" device in both groups and between groups
Time frame: Month 12
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time frame: Day -15
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time frame: Month 3
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups
Time frame: Month 12
Compare the sensitive conduction velocity in both groups and between groups
Time frame: Day -15
Compare the sensitive conduction velocity in both groups and between groups
Time frame: Month 3
Compare the sensitive conduction velocity in both groups and between groups
Time frame: Month 12
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Time frame: Day -15
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Time frame: Month 3
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"
Time frame: Month 12
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Time frame: Day -15
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Time frame: Month 3
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire
Time frame: Month 12
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Day -15
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Month 3
Analysis of post-ischemic hyperemia using the laser doppler Perimed.
Time frame: Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonia PEREZ-MARTIN, Pr principal investigator
Nîmes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vascularly biological assessment, Analysis of vasomotor endothelial function and Analysis of arterial compliance in people with Bariatric Surgery and Obese, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reactive Hyperemia Index (RHI) (time frame: day -15). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.