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)

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)

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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