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)

C

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Obese
Type2 Diabetes
Bariatric Surgery

Treatments

Biological: Intima-Media Thickness measurement
Behavioral: level of physical activity
Biological: Analysis of arterial compliance
Biological: Venous Doppler Ultrasound
Other: thoracic scanner
Biological: Vascularly biological assessment
Biological: Arterial pressure measurement
Biological: Exploration of neuropathy
Biological: Exploration of microcirculation
Biological: Analysis of vasomotor endothelial function

Study type

Interventional

Funder types

Other

Identifiers

NCT03636243
NIMAO/2017-02/APM-01

Details and patient eligibility

About

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.

Enrollment

36 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

36 participants in 2 patient groups

Group of obese patients with type-2 diabetes
Other group
Treatment:
Biological: Exploration of microcirculation
Biological: Analysis of vasomotor endothelial function
Biological: Exploration of neuropathy
Biological: Arterial pressure measurement
Biological: Vascularly biological assessment
Behavioral: level of physical activity
Biological: Venous Doppler Ultrasound
Biological: Analysis of arterial compliance
Biological: Intima-Media Thickness measurement
Group of non-diabetic obese patients
Other group
Treatment:
Biological: Exploration of microcirculation
Biological: Analysis of vasomotor endothelial function
Biological: Exploration of neuropathy
Biological: Arterial pressure measurement
Biological: Vascularly biological assessment
Other: thoracic scanner
Behavioral: level of physical activity
Biological: Venous Doppler Ultrasound
Biological: Analysis of arterial compliance
Biological: Intima-Media Thickness measurement

Trial contacts and locations

1

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Central trial contact

Antonia PEREZ-MARTIN, Pr

Data sourced from clinicaltrials.gov

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