Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome

NCT ID: NCT02851602

Last Updated: 2019-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-18

Study Completion Date

2016-11-14

Brief Summary

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HDL in obese non-diabetic patients show major alterations in their function and thus their cardio-protective effects. These alterations could be explained by the quantitative and qualitative anomalies in the phospholipids and sphingolipids in the HDL. These molecules play a major role in HDL function and probably present early modifications in obesity, even before the onset of glycaemia deregulation.

The aim of this study is to show the presence of qualitative and quantitative modifications of phospholipids and sphingolipids in HDL from obese patients compared with HDL from non-obese controls.

Detailed Description

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Conditions

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Metabolic Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Obese

Group Type EXPERIMENTAL

Blood sample

Intervention Type BIOLOGICAL

control

Group Type PLACEBO_COMPARATOR

Blood sample

Intervention Type BIOLOGICAL

Interventions

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Blood sample

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* aged \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \> 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
* 2 criteria among the following 3 (NCEP/ATP III criteria for metabolic syndrome):
* triglyceridaemia ≥ 1.50 g/l
* HDL cholesterol \< 0.40 g/l for men and 0.50 g/l for women
* arterial blood pressure ≥ 130/85 mmHg or treatment for arterial hypertension
* age \> 18 years
* fasting glycaemia \< 1.10 g/l
* waist circumference \< 102 cm for men and 88 cm for women
* triglyceridaemia \< 1.50 g/l
* HDL cholesterol ≥ 0.40 g/l for men and 0.50 g/l for women
* Healthy subjects who have provided written consent

Exclusion Criteria

* Persons without national health insurance cover
* Diabetes
* Diseases that interfere with lipoprotein metabolism (dysthyroidism not controlled with the treatment, kidney or liver disease)
* Treatments that interfere with lipoprotein metabolism (lipid-lowering agents, oestrogens, corticoids, retinoids, antiretroviral agents)
* Pregnancy/breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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VERGES 2013

Identifier Type: -

Identifier Source: org_study_id

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