Study of Coffee and Its Influence on the Heart in Normal People, Those With Coronary Artery Disease and Diabetics.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
研究概览
简要总结
Coffee is a worldwide drink, been part of any culture. There are some concerns about effects of coffee on the health. Recently, epidemiological studies have shown benefits of coffee drinking to diabetics and also to prevent diabetes in populations. We aim to understand some effects of coffee and not only caffeine over vascular system, in special coronary artery disease patients, diabetics end normal people.
详细描述
Patients will have a wash-out period (21 days) with no coffee or other caffeine-drinks. Then they will be submitted to treadmill test, MAPA, Holter-ECG and vascular reactivity study, biochemical and inflammatory plasma dosages, as basal. Then they will start a period of coffee drinking over 4 weeks; and all exams will be repeated. We will study two types of coffee, arabica and robusta; with two types of toasted beans(regular and soft). Also regular and decaffeinated coffee. A total of 300 (100 normal people, 100 diabetics, 100 coronary disease) individuals will be tested.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal Volunteers:
- •Healthy volunteer.
- •Age between 20 and 80 years.
- •No addict to drugs.
- •Absence of chronicle diseases.
- •No alcohol abuse.
- •Coronary artery disease:
- •Presence of coronary artery disease, by coronary angiography
- •Stable angina, class 1-3 of CCS.
- •Age between 20 and 80 years.
- •Treadmill effort test with ischemia.
- •No alcohol abuse.
- •Presence of type II Diabetes on oral treatment.
- •Age between 20 and 80 years.
- •Absence of chronicle diseases, except diabetes.
- •No alcohol abuse.
排除标准
- •Normal Volunteers:
- •Any blood test with twice or more the upper limit range.
- •Presence of enlarged QRS.
- •Coronary artery disease:
- •Any blood test with twice or more the upper limit range even with treatment.
- •Presence of enlarged QRS.
- •Ventricular dysfunction (EF < 45%).
- •Blood glucose greater than 160 mg/dL.
- •Others blood tests with twice or more the upper limit range even with treatment.
- •Presence of enlarged QRS.
结局指标
主要结局
Verify the relationship between coffee ingestion and cardiovascular morbidity and mortality
时间窗: 10 years of follow-up
次要结局
- Relationship between coffee ingestion and cardiovascular risk factors(10 years)
研究者
Luiz Antonio M. Cesar
Professor of Medicine
University of Sao Paulo