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

Not Applicable

Active, not recruiting

• Conditions: Bariatric Surgery; Type2 Diabetes; Obese
• Interventions: 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

• Registration Number: NCT03636243
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Study Start: 2019-10-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-09
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 37

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Reactive Hyperemia Index (RHI)	Month 3	Measured to the finger by tonometry using the "Endo-Pat 2000 device"

Secondary Outcome Measures

Name	Time	Method
Compare the sweat function using the" Sudoscan" device in both groups and between groups	Day -15	µV
Reactive Hyperemia Index (RHI)	day -15, Month 12	reactive hyperemia index (%)
Compare the concentration of the soluble fms-like tyrosine kinase-1 markers of endothelial function in both groups and between groups	Month 12	pg/mL
Compare the vibratory sensitivity using a neurothesiometer in both groups and between groups	Month 12	Hz
Evaluate the presence of neuropathic pain using the questionnaire "Neuropathic Pain in 4 Questions"	Month 12	If the score is greater than or equal to 4, the test is positive.
Analysis of cutaneous vasomotion using the laser doppler Perimed.	Month 12
Compare the concentration of the vascular endothelial growth factor marker of endothelial function in both groups and between groups	Month 12	pg/mL
Evaluate the physical activity	Month 12	number of steps in previous 4 days
Compare the sensitive conduction velocity in both groups and between groups	Month 12	m/s
Compare the concentration of the fibrinogen marker of endothelial function in both groups and between groups	Month 12	g/L
Compare the concentration of the D-dimer marker of endothelial function in both groups and between groups	Month 12	ng/ml
Creation of a biobank	Month 12	storage of blood sample
Compare toe pressure using the SysToe device in both groups and between groups	Month 12	mmHg
Compare the sweat function using the "Sudoscan" device in both groups and between groups	Month 12	µV
Evaluate the quality of life using the "Quality Of Life, Obesity and Dietetics" questionnaire	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.
Analysis of post-ischemic hyperemia using the laser doppler Perimed.	Month 12
study of the peri-aortic and peri-brachial adipose tissue (TAPV)	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

Trial Locations

Locations (1)

CHU Nimes; 🇫🇷 Nîmes, France