Development of Endothelial Biomarkers

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Induction of endothelial function variations

• Registration Number: NCT02006810
• Lead Sponsor: University Hospital, Clermont-Ferrand

Brief Summary

The main objective is to develop and validate new endothelial function markers discriminating and reproducible by assessing the ability to reveal changes in endothelial function in response to positive and negative nutritional stimuli.

Detailed Description

The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-09-24
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Primary Completion: 2016-12-19
• Study Completion: 2017-09-19
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-04
• Last Update Posted: 2018-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• • 40 to 65 years old
• male
• non-smokers

Specific inclusion criteria for healthy subjects :

• Healthy subjects should not take antihypertensive or statin.
• Healthy subjects should not present metabolic syndrome but one criterion of the metabolic syndrome will be tolerated.

Specific inclusion criteria for subjects with metabolic syndrome :

• subjects with metabolic syndrome must have at least 3 of the 5 criteria associated with the metabolic syndrome.

Exclusion Criteria

• treatment vasodilator nitric oxide liberating,
• diabetes and coronary artery disease,
• chronic alcoholism,
• severe hepatic impairment,
• end stage renal failure or dialysis,
• neurological tremor,
• cancer, mental illness or other severe disease which can impact informed consent and / or results,
• Refusal to be registered in the National File of Volunteers
• Person in exclusion of the National Volunteer File

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
flavonoids	Induction of endothelial function variations	The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).
lipids	Induction of endothelial function variations	The study will be randomized (on the order of taking the products: a single dose of lipids or a single dose of flavonoids), single-blinded, cross-over for each population (healthy and metabolic syndrome).

Primary Outcome Measures

Name	Time	Method
Flow Mediated Dilatation (FMD)compared to hyperemic velocity time integral (VTI) and endothelial microparticles (MPE)	at 150 mn after the product intake	Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: - Flow Mediated Dilatation (FMD) (reference); Compared to: * Hyperemic Velocity Time Integral (VTI); * Endothelial microparticles (MPE)

Secondary Outcome Measures

Name	Time	Method
Changes in endothelial function evaluated by cell adhesion molecule (CAM) and micro-RNA (miRNA)	at 150 mn after the product intake	Changes in endothelial function from baseline at 150 mn after the product intake, evaluated by: * Cell Adhesion Molecule (CAM); * Micro-RNA (miRNA)

Trial Locations

Locations (1)

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France