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

Not Applicable

Completed

• Conditions: Metabolic Syndrome
• Interventions: Biological: Blood sample

• Registration Number: NCT02851602
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

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

Not available

Study Timeline

• Study Start: 2013-11-18
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-29
• Study First Posted: 2016-08-01
• Primary Completion: 2016-11-14
• Study Completion: 2016-11-14
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-09
• Last Update Posted: 2019-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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
• patients who have provided written consent INCLUSION CRITERIA FOR HEALTHY SUBJECTS
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Blood sample	-
Obese	Blood sample	-

Primary Outcome Measures

Name	Time	Method
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass	At inclusion	in patients with abdominal obesity without hyperglycaemia compared with healthy controls

Secondary Outcome Measures

Name	Time	Method
Difference in the percentage of each sub-family according to the nature of the fatty acids for phosphatidylcholines on the one hand and sphingomyelins on the other in patients	At inclusion	with abdominal obesity but without hyperglycaemia compared with healthy control
Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids	At inclusion	in patients with abdominal obesity but without hyperglycaemia compared with healthy controls

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France