OIVITA: Observatory on Impact of Life Styles on Health Outcomes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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) .
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| general population the study is open to all population, (14-90 years, male/female) to verify the impact of lifestyles (mediterranean style) on intermediate and hard endpoint. |
Outcome Measures
Primary Outcome Measures
- cardiovascular events [10 year]
Presence of events in the anamnesis of subjects enrolled
Secondary Outcome Measures
- cardiovascular risk [10 years]
Framingham Risk Score
Other Outcome Measures
- vitamin D profile [10 years]
vitamin d serum levels will be assessed and compared to the life style
- vitamin B12 profile [10 years]
vitamin b12 serum levels will be assessed and compared to the life style
- Folic Acid profile [10 years]
folic acid serum levels will be assessed and compared to the life style
Eligibility Criteria
Criteria
Inclusion Criteria:
- General population
Exclusion Criteria:
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Subjects who do not sign informed consent and do not give authorization will be excluded from the study
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Subjects fed through parenteral feeding
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | San Giovanni e Ruggi Hospital | Salerno | Italy | 84100 |
Sponsors and Collaborators
- Guido Iaccarino
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1234