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

University Hospital Center (CHU) Dijon Bourgogne

Status: Completed

Conditions: Metabolic Syndrome

Treatments: Biological: Blood sample

Study type: Interventional

Funder types: Other

Identifiers

NCT02851602

VERGES 2013

Details and patient eligibility

About

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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

89 participants in 2 patient groups, including a placebo group

Obese

Experimental group

Treatment:

Biological: Blood sample

control

Placebo Comparator group

Treatment:

Biological: Blood sample