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临床试验/NCT03305276
NCT03305276Unknown不适用

Evaluation of the Impact of Mediterranean Lifestyle and Diet on Intermediate and Final Endpoints of Health

Guido Iaccarino1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2014年5月16日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,500
试验地点
1
主要终点
cardiovascular events

研究概览

简要总结

The present is an observational study conducted on the general population in villages of Southern Italy every year during the world hypertension day. So far, A total of 412 persons (193 males and 219 female, 14-85 years) were recruited during the XI and XII World Hypertension Day (2015 and 2016). The study was approved by the relevant institutional Ethical Committee of Salerno University.

详细描述

In occasion of the World Hypertension Day in may , boots are organized in the major squares of the southern italy villages, and volunteers of the Medical School of Salerno collect through means of questionnaires, anamnestic data and dietary habits, and measure blood pressure after 5 minutes in the sitting position, 3 times with an interval of 2 minutes using validated, ESH approved electronic oscillometer (A100, Microlife, Italy), according to the ESC/ESH guidelines. Other questions regard previous cardiovascular conditions or events (coronary heart disease) and cardiovascular accidents (TIA and stroke). Eventual drug treatment and Vitamin D supplementation is also annotated. A venous blood sample is drawn from the antecubital vein and blood is stored for biochemical analysis at the University Hospital Centralized Service. Data are digitally stored for analysis.

Anamnestic and biochemical data regarding age, sex-specific cholesterol, HDL cholesterol, systolic BP and cigarette smoking pre-existing conditions and way of life are used for the calculation of cardiovascular risk according to the Framingham Cardiovascular Risk Score. Familiarity for cardiovascular disease is defined as cardiovascular events in parents and siblings less than 50 years old.

The validated questionnaire alternate Mediterranean Diet Score (aMed), is administered to assess adherence to the Mediterranean Diet . Laboratory assessment of blood samples. A venous blood sample was collected in two tubes of 5.0 ml and centrifuged in the day. The time of the last meal was recorded during the data collection. Blood glucose, insulin, blood urea nitrogen (BUN), creatinine, calcium, phosphorus, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, 25(OH)D, PTH, Vitamin B-12 and folic acid are assessed. Glomerular filtration rate (GFRs) is estimated using the equation of Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) .

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Retrospective

入排标准

年龄范围
14 Years 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •General population

排除标准

  • •Subjects who do not sign informed consent and do not give authorization will be excluded from the study
  • •Subjects fed through parenteral feeding

结局指标

主要结局

cardiovascular events

时间窗: 10 year

Presence of events in the anamnesis of subjects enrolled

次要结局

  • cardiovascular risk(10 years)

研究者

发起方
Guido Iaccarino
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Guido Iaccarino

Associate Professor of Internal Medicine

Azienda Ospedaliera OO.RR. S. Giovanni di Dio e Ruggi D'Aragona

研究点 (1)

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