Association Between HDL Functions and Atherosclerotic Burden in Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 101
- 试验地点
- 1
- 主要终点
- Cholesterol efflux capacity of HDL
研究概览
简要总结
This is a study of HDL function in healthy individuals classified in three groups according to their HDL-cholesterol levels (Low HDL-C, Intermediate HDl-C and High HDL-C), with the purpose of investigating which characteristics of the HDL particle might be associated to atherosclerotic burden, characterized by carotid intima-media thickness above 1mm.
详细描述
Selection: Study participants are initially selected trough the evaluation of consecutive lipid profiles from individuals who spontaneously seek governmental primary care centers of the city of Campinas, Sao Paulo, Brazil. Telephone-based screening interviews are performed, followed by in-person clinical evaluation and blood exams.
Biochemical analyses: Glucose, triglycerides, HDL-C and c-reactive protein (CRP) are measured in an automated Modular® Analytics Evo (Roche Diagnostics, Burgess Hill, West Sussex, UK), using Roche Diagnostics® reagents (Mannheim, Germany). LDL-cholesterol is calculated by the Friedewald formula. Serum insulin levels are measured using ELISA (Millipore, Massachusetts, USA). The Homeostasis Model Assessment (HOMA) Calculator version 2.2 (University of Oxford, UK) is used to estimate insulin sensitivity. Apolipoproteins A-I and B-100 and lipoprotein (a) are determined by nephelometry in an automated system and reagents from Dade-Behring® (Marburg, Germany).
Carotid artery ultrasound: Carotid artery atherosclerosis is estimated by using high-resolution B-mode ultrasound, at the posterior wall of the common carotid artery.
Lipoprotein isolation: HDL from each study participant is isolated from plasma, through ultracentrifugation (Beckman Coulter Inc., Palo Alto, USA).
HDL chemical composition: Using commercially available enzymatic kits, HDL content of total proteins, total cholesterol, free cholesterol, phospholipids, triglycerides and apolipoprotein A-I are measured. Cholesteryl ester (CE) is calculated as the difference between total cholesterol and free cholesterol times 1.67. HDL molar concentration is estimated based on particle total mass and molecular weight.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •glucose <100 mg/dL
- •Urea <71 mg/dL
- •Creatinine < 1.20 mg/dL
- •Uric acid <7.0 mg/dL
- •Alanine aminotransferase <50 U/L
- •Aspartate aminotransferase < 33 U/L
- •Gamma-glutamyl transferase <71 U/L
- •Alkaline phosphatase <129 U/L
- •Thyroid stimulating hormone between 0.41 and 4.50 μUI/mL
- •Free thyroxin between 0.9 and 1.8 ng/dL
排除标准
- •Symptomatic cardiovascular disease
- •LDL-cholesterol ≥130 mg/dL
- •Triglycerides ≥150 mg/dL
- •Metabolic syndrome
- •BMI ≥ 30 kg/m2
- •Smoking habit
- •Daily intake of alcohol >14g
- •Regular use of medical treatments
结局指标
主要结局
Cholesterol efflux capacity of HDL
时间窗: The analysis will be performed using plasma obtained at admission into the study
This is a cross-sectional study and as such the cholesterol efflux capacity will be measured using the plasma sample collected at admission into the study
次要结局
- Antioxidant activity of HDL(The analysis will be performed using plasma obtained at admission into the study)
- Anti-inflammatory activity of HDL(The analysis will be performed using plasma obtained at admission into the study)
- Platelet aggregation inhibition by HDL(The analysis will be performed using plasma obtained at admission into the study)
- Susceptibility to oxidation of HDL(The analysis will be performed using plasma obtained at admission into the study)
研究者
Andrei Carvalho Sposito
Professor of Cardiology
University of Campinas, Brazil