Qualitative and Quantitative Characterization of HDL in T2D After Fenofibrate or Niacin Treatment in Spanish Population
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L
研究概览
简要总结
The structural and functional alterations of high density lipoproteins (HDL) levels in type 2 diabetes (T2D) patients linked to hypertriglyceridemia, hyperglycemia, insulin resistance, inflammation and oxidation, play a major role in the increased macrovascular risk in these patients. An impaired function of the adipose tissue (AT) in T2D contributes to low HDL concentrations.
Objectives: 1) Quantitative and qualitative characterisation of HDL subclasses by ultracentrifugation, proteomic and metabolomic techniques. 2) To study the relationship between the HDL subclasses, preβ1 HDL and remnant HDL, and clinical determinants of arteriosclerosis. 3) Functional in vitro studies of the HDL subclasses determined in Objective 1. 4) To study the role of AT determining the low HDL levels. 5) To study the impact of HDL increasing drugs on HDL qualitative changes.
详细描述
Groups of subjects: a) Diabetic patients with low HDL; b) Non-diabetic patients with low HDL; c) Diabetic patients with normal HDL levels; and d) Non-diabetic patients with normal HDL levels. The studies will be performed after washing out lipid lowering drugs. Intima media thickness (IMT) will be performed in all groups. Main biochemical techniques will be centralised. Isolation and characterisation of HDL subclasses and remnant HDL, as well as a determination and preβ1 HDL will be performed. HDL studies examining HDL proteomic and metabolomic profiles will be performed. Functional studies will determine the effects on the endothelium, inflammation, cholesterol efflux and oxidation according the qualitative changes. These HDL measurements will be repeated in group (a), after they are treated with fibrates or Niacin. HDL metabolism in adipocytes will be extensively studied, and the clinical associations between HDL alterations and plasma AT-derived molecules will be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetic patients
- •Age from 30 years to 70 years
- •HDL not exceeding 50 mg/dl in men or 60 mg/dl in women
排除标准
- •to be a smoker
- •To be diagnosed with diabetes less than three months before
- •To have triglyceride levels above 400 mg/dl
- •Glycated hemoglobin higher than 9%
- •Albuminuria above 300 mg/mg creatinine
- •Chronic kidney disease (eFGR <30 ml/min/1.73 m2)
- •Advanced retinopathy
- •Neuropathy
- •Cardiovascular disease in the last three months
- •Chronic liver insufficiency
- •Neoplastic disease or any chronic or incapacitating disease
研究组 & 干预措施
Fenofibrate
Fenofibrate 145 mg/day for 12 weeks
干预措施: Fenofibrate (Drug)
Niacin plus Laropiprant
Niacin 2g/day plus Laropiprant for 12 weeks
干预措施: Niacin plus laropiprant (Drug)
结局指标
主要结局
HDL particles size and number assessed by nuclear magnetic resonance (NMR) and reported as nm and micromol/L
时间窗: Two periods of 12 weeks treatment according to crossing over design
HDL particles were studied by NMR in T2D patients after treatment with fenofibrate or Niacin
次要结局
- Apolipoprotein A1 (Apo A1), apolipoprotein A2 (Apo A2), paraoxonase (PON) HDL concentration (g/l - mg/l)(Two periods of 12 weeks treatment according to crossing over design)
研究者
LUIS MASANA, MD
Professor
Institut Investigacio Sanitaria Pere Virgili