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临床试验/NCT02851602
NCT02851602已完成不适用

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

Centre Hospitalier Universitaire Dijon2 个研究点 分布在 1 个国家目标入组 89 人开始时间: 2013年11月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
89
试验地点
2
主要终点
Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Persons without national health insurance cover
  • 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

研究组 & 干预措施

Obese

Experimental

干预措施: Blood sample (Biological)

control

Placebo Comparator

干预措施: Blood sample (Biological)

结局指标

主要结局

Difference in the mass percentages of total phospholipids + sphingolipids compared with the total HDL mass

时间窗: At inclusion

in patients with abdominal obesity without hyperglycaemia compared with healthy controls

次要结局

  • 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)
  • Difference in the percentage of each family of phospholipids or sphingolipids compared with total phospholipids + sphingolipids(At inclusion)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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