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

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Centre Hospitalier Universitaire Dijon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Dijon Bourgogne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Obese

control

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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

Full Information

First Posted
July 28, 2016
Last Updated
January 9, 2019
Sponsor
Centre Hospitalier Universitaire Dijon
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1. Study Identification

Unique Protocol Identification Number
NCT02851602
Brief Title
Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Acronym
SPHINGO
Official Title
Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
November 18, 2013 (Actual)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
November 14, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire Dijon

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Obese
Arm Type
Experimental
Arm Title
control
Arm Type
Placebo Comparator
Intervention Type
Biological
Intervention Name(s)
Blood sample
Primary Outcome Measure Information:
Title
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass
Description
in patients with abdominal obesity without hyperglycaemia compared with healthy controls
Time Frame
At inclusion
Secondary Outcome Measure Information:
Title
Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids
Description
in patients with abdominal obesity but without hyperglycaemia compared with healthy controls
Time Frame
At inclusion
Title
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
Description
with abdominal obesity but without hyperglycaemia compared with healthy control
Time Frame
At inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CHU Dijon Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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