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Completed

NCT Number: NCT02851602

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: SPHINGO

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Aug 1, 2016
Registry last updated
Jan 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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