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

Metabolic Syndrome Clinical Trial

— SPHINGO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02851602
• Other study ID #: VERGES 2013
• Status: Completed
• Phase: N/A
• Start date: November 18, 2013
• Est. completion date: November 14, 2016

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: November 14, 2016
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Biological:
• Blood sample

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass	in patients with abdominal obesity without hyperglycaemia compared with healthy controls	At inclusion
Secondary	Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids	in patients with abdominal obesity but without hyperglycaemia compared with healthy controls	At inclusion
Secondary	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	with abdominal obesity but without hyperglycaemia compared with healthy control	At inclusion