A Study to Assess the Consequences of Postprandial Lipemia in CRP as Inflammatory Marker in High-risk Adults, to Investigate Whether Hypolipidemic, Hypoglycemic or Antihypertensive Medication May Lessen the Exaggerated Postprandial Lipemia and Evaluate the Influence of Gene Polymorphisms Involved in Lipid and Glucose Metabolism on Postprandial Lipemia and Cardiovascular Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 580
- 试验地点
- 1
- 主要终点
- Change in CRP levels
研究概览
简要总结
Coronary heart disease (CHD) is the leading cause of death worldwide. The disease is characterized by a high mortality rate (about 40%) and a course continuously altered by lifestyle, gene polymorphisms and therapeutic treatment. Fasting concentration of blood lipids and lipoproteins only partially express the complex relation between dyslipidemia and CHD. Following the indication stated nearly 40 years ago by Zilversmit, there is now accumulating evidence that postprandial lipemia plays an important role in the atherogenic process [ref Kolovou], particularly that most hours of the day are spent in the postprandial state. Furthermore, the increases in blood glucose and triglycerides (TGs) following meals stimulate oxidative stress, impair endothelial function, and rises the inflammatory factors that lead to atherosclerosis. Previous studies reported on postprandial lipemia in subjects with obesity, metabolic syndrome, diabetes mellitus, elderly, patients with CHD and others. However, currently the estimation of cardiovascular disease risk is based on fasting blood values of triglycerides (TGs) and inflammatory markers. The effect of postprandial atherogenic factors on the initiation and progression of atherosclerosis is actually not known.The Hellenic Postprandial Lipemia Study (HPLS) was designed to study the consequences of postprandial lipemia in CRP as inflammatory marker in high-risk adults. Furthermore, the HPLS study will investigate whether hypolipidemic, hypoglycemic or antihypertensive medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal postprandial metabolism. Finally, the HPLS study is intending to evaluate the influence of gene polymorphisms involved in lipid and glucose metabolism on postprandial lipemia and cardiovascular outcomes.
详细描述
The study aims to recruit 1200 patients that are characterized either as high risk or very-high risk for Coronary Heart Disease. It is assumed that an equal number of high risk and very high risk patients will be included in the study. Patients will be invited to participate in the study from outpatient clinics in the 14 centers in Athens, Greece.
The study will be approved by the institution ethics committee and informed consent will be obtained from all participating patients.
Participating patients will have recently (up to 15 days) been initiated in one of the following dislipidemic treatments:
- Simvastatin up to 40 mg,
- Atorvastatin up to 80 mg,
- Rosuvastatin up to 40 mg,
- Statin intolerant subjects receiving colesevelam up to 3.75 g/day or fenofibrate 145 mg/day.
All patients should have received the above treatments as initial treatment for dyslipidemia with the exception of statin intolerant patients. All patients at the time of their inclusion in the study will have been evaluated for gene polymorphisms as part of their dyslipidemic profile evaluation. Furthermore patients will have been characterized as high risk or very high risk according to the SCORE level of risk, calculated using the Greek version of low-risk regions charts.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients ≥ 18 years of age,
- •Signed informed consent form
- •Fasting triglycerides (TGs) < 220 mg/dl
- •Liver function tests within normal range
- •No more than mild renal impairment (clearance of creatinine >60 ml/min)
- •features of very high risk
- •documented cardiovascular disease by invasive or non-invasive testing (such as coronary angiography, nuclear imaging, stress echocardiography, carotid plaque on ultrasound)
- •previous myocardial infarction
- •acute coronary syndrome
- •coronary revascularization (percutaneous coronary intervention, coronary artery bypass graft) and other arterial revascularization procedures
- •ischemic stroke
- •peripheral artery disease
- •patients with type 2 diabetes
- •patients with type 1 diabetes with target organ damage
- •calculated 10 year risk SCORE ≥10%] or
- •high risk, markedly elevated single risk factors such as:
- •familial dyslipidemias and severe hypertension
- •calculated SCORE ≥5% and <10%
排除标准
- •history of liver, kidney, pancreas, or gall bladder disease,
- •history of acute coronary syndrome one month prior to entering the study
- •pregnancy
- •presence of any inflammatory disease
- •treatment with medications known to affect TGs metabolism or concentration
结局指标
主要结局
Change in CRP levels
时间窗: 0,6,12,18,24,30,36 months
To study the consequences of postprandial lipemia in CRP as inflammatory marker in high-risk adults.
Change in exaggerated postprandial lipemia
时间窗: 0,3,6,12,18,24,30,36 months
To investigate whether hypolipidemic, hypoglycemic or antihypertensive medication may lessen the exaggerated postprandial lipemia as well as the rest abnormal postprandial metabolism.
Change in Lipotest meal values
时间窗: 0,3,6,12,18,24,30,36 months
To study the impact of postprandial lipemia using a novel test (Lipotest meal) that distinguishes very-high and high risk subjects in to two subgroups according to first Lipotest meal: the positive group with TG postprandial ≥220 mg/dl, and the negative group with TG postprandial \< 220 mg/dl (Consensus criteria).
次要结局
- Number of major adverse cardiovascular events(0-36 months)