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Trial record 14 of 182 for:    Phospholipids

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

Tracking Information
First Submitted Date  ICMJE July 28, 2016
First Posted Date  ICMJE August 1, 2016
Last Update Posted Date January 10, 2019
Actual Study Start Date  ICMJE November 18, 2013
Actual Primary Completion Date November 14, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02851602 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 29, 2016)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
Official Title  ICMJE Phospholipid and Sphingolipid Composition of High-density Lipoproteins (HDL) in Obese Non-diabetic Patients With Metabolic Syndrome
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE Biological: Blood sample
Study Arms  ICMJE
  • Experimental: Obese
    Intervention: Biological: Blood sample
  • Placebo Comparator: control
    Intervention: Biological: Blood sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 9, 2019)
89
Original Actual Enrollment  ICMJE
 (submitted: July 29, 2016)
100
Actual Study Completion Date  ICMJE November 14, 2016
Actual Primary Completion Date November 14, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02851602
Other Study ID Numbers  ICMJE VERGES 2013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor  ICMJE Centre Hospitalier Universitaire Dijon
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP