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

NCT02851602 | Completed

• 1 other identifier: VERGES 2013
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids

  At inclusion

• 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

Study Arms (2)

Obese

EXPERIMENTAL

Biological: Blood sample

control

PLACEBO COMPARATOR

Biological: Blood sample

Interventions

Blood sample BIOLOGICAL

Obese; control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged \> 18 years
• fasting glycaemia \< 1.10 g/l
• waist circumference \> 102 cm for men and 88 cm for women (criteria NCEP/ATP III)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

Location

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2016
• First Posted: August 1, 2016
• Study Start: November 18, 2013
• Primary Completion: November 14, 2016
• Study Completion: November 14, 2016
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

FR (1)