Effects of Adherence to a Mediterranean Diet Style on Cardiovascular Risk by Means Its Influence on Serum Levels of Ceramides and on Some Atherothrombotic Candidate Gene Expression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 2
- 主要终点
- Effects on metabolic variables
研究概览
简要总结
Evaluation of the effect of adherence to Mediterranean Diet on some surrogate vascular markers and on gene expression of some cardiometabolic genes
详细描述
The investigators have designed a study project to evaluate in a sample of patients with high cardiovascular risk:
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The effects of adherence to Mediterranean Diet on serum levels of some metabolic variables (glucose blood levels, serum LDL cholesterol, serum total cholesterol, serum triglycerides)
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The effects of adherence to Mediterranean Diet on serum levels of some ceramides and of adiponectin and resistin at 6 and 12-month follow-up
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The effects of adherence to a Mediterranean Diet style on some surrogate markers of vascular damage such ad endothelial function measured by means of the evaluation of reactive hyperemia index (RHI) and arterial stiffness markers (PWV, AIX) at 6 and 12-month follow-ups
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The effects of adherence to Mediterranean Diet on the genetic expression of some cardiometabolic and atherothrombotic candidate genes at 12-month follow-up
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The effects of the Mediterranean diet adherence on the incidence of cardio and cerebrovascular events at 12 and 18 month follow-ups considering respectively:
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composite endpoint: myocardial infarction, ischemic stroke and death from cardiovascular causes
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secondary endpoint: myocardial infarction, stroke, death from cardiovascular causes
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least two of the following eligibility criteria:
- •Type 2 diabetes mellitus
- •Arterial hypertension
- •Active smoking
- •Family history of early cardiovascular disease
- •Previous cardiovascular or cerebrovascular events (> 6 months)
排除标准
- •All patients with recent (<6 months) cardiovascular or cerebrovascular events were excluded.
结局指标
主要结局
Effects on metabolic variables
时间窗: Baseline to 12 months
Effects of adherence to Mediterranean Diet in determining a change in serum levels of some metabolic variables (glucose blood levels in mg/dl, serum LDL cholesterol in mg/dl, serum Total cholesterol in mg/dl, serum triglycerides in mg/dl) from baseline to 12 months.
次要结局
- Effects on arterial stiffness indexes(Baseline to 12 months)
- effects on serum resistin serum levels(Baseline to 12 months)
- effects on serum ceramides.(Baseline to 12 months)
- effects on adiponectin serum levels(Baseline to 12 months)
- Effects on cardiovascular events(Baseline to 24 months)
- Effects on surrogate cardiovascular marker (endothelial dysfunction)(Baseline to 12 months)
- effects on gene expression(Baseline and12 months)
研究者
Antonino Tuttolomondo
Professor
University of Palermo