NCT03636243

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 15, 2019

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

5.9 years

First QC Date

August 16, 2018

Last Update Submit

January 6, 2025

Conditions

Bariatric SurgeryObeseType2 Diabetes

Outcome Measures

Primary Outcomes (2)

  • Reactive Hyperemia Index (RHI)

    Measured to the finger by tonometry using the "Endo-Pat 2000 device"

    day -15

  • Reactive Hyperemia Index (RHI)

    Measured to the finger by tonometry using the "Endo-Pat 2000 device"

    Month 3

Secondary Outcomes (44)

  • Reactive Hyperemia Index (RHI)

    day -15, Month 12

  • Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups

    day -15

  • Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups

    Month 3

  • Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups

    Month 12

  • Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups

    Day -15

  • +39 more secondary outcomes

Study Arms (2)

Group of obese patients with type-2 diabetes

OTHER
Biological: Vascularly biological assessmentBiological: Analysis of vasomotor endothelial functionBiological: Analysis of arterial complianceBiological: Exploration of microcirculationBiological: Venous Doppler UltrasoundBiological: Arterial pressure measurementBiological: Intima-Media Thickness measurementBiological: Exploration of neuropathyBehavioral: level of physical activity

Group of non-diabetic obese patients

OTHER
Biological: Vascularly biological assessmentBiological: Analysis of vasomotor endothelial functionBiological: Analysis of arterial complianceBiological: Exploration of microcirculationBiological: Venous Doppler UltrasoundBiological: Arterial pressure measurementBiological: Intima-Media Thickness measurementBiological: Exploration of neuropathyBehavioral: level of physical activityOther: thoracic scanner

Interventions

Vascularly biological assessmentBIOLOGICAL

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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
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.

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
Exploration of microcirculationBIOLOGICAL

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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
Venous Doppler UltrasoundBIOLOGICAL

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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
Intima-Media Thickness measurementBIOLOGICAL

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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
Exploration of neuropathyBIOLOGICAL

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

Group of non-diabetic obese patientsGroup of obese patients with type-2 diabetes
level of physical activityBEHAVIORAL

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 patientsGroup of obese patients with type-2 diabetes
thoracic scannerOTHER

non-injected thoracic scanner visit at month 3

Group of non-diabetic obese patients

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • The subject participates in another interventional 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antonia PEREZ-MARTIN, Pr

    Nîmes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 17, 2018

Study Start

October 15, 2019

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

FR(1)