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

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ClinicalTrials.gov Identifier: NCT02851602
Recruitment Status : Completed
First Posted : August 1, 2016
Last Update Posted : January 10, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Biological: Blood sample Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : November 18, 2013
Actual Primary Completion Date : November 14, 2016
Actual Study Completion Date : November 14, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Obese Biological: Blood sample
Placebo Comparator: control Biological: Blood sample



Primary Outcome Measures :
  1. Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: At inclusion ]
    with abdominal obesity but without hyperglycaemia compared with healthy control



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02851602


Locations
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France
CHU Dijon Bourgogne
Dijon, France, 21079
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02851602     History of Changes
Other Study ID Numbers: VERGES 2013
First Posted: August 1, 2016    Key Record Dates
Last Update Posted: January 10, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases