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

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Completed
CT.gov ID
NCT02851602
Collaborator
(none)
89
Enrollment
1
Location
2
Arms
35.9
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Blood sample
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
89 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Actual Study Start Date :
Nov 18, 2013
Actual Primary Completion Date :
Nov 14, 2016
Actual Study Completion Date :
Nov 14, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: Obese

Biological: Blood sample
Placebo Comparator: control

Biological: Blood sample

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Dijon Bourgogne Dijon France 21079

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02851602
Other Study ID Numbers:
  • VERGES 2013
First Posted:
Aug 1, 2016
Last Update Posted:
Jan 10, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms:
Metabolic Syndrome
Syndrome

Study Results

No Results Posted as of Jan 10, 2019