Heart Disease Clinical Trial
Official title:
Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population (SARDINIA)
Verified date | January 2, 2015 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background:
- The island of Sardinia, an Italian region, has a population that is highly interrelated.
Researchers have developed the SardiNIA longitudinal study to examine the possible genetic
factors that predispose individuals to diseases and to various inherited conditions. In the
study, participants will be drawn from four towns in the Ogliastra region (Lanusei, Ilbono,
Elini, and Arzana), and their DNA will be analyzed and compared with a long-term assessment
of various health-related events. The SardiNIA study is designed to improve understanding of
the genetic factors involved in age-associated diseases and disorders, and provide possible
points of intervention that may help prevent diseases.
Objectives:
- To conduct a long-term study of genetics and epidemiology in a small and highly
interrelated population.
Eligibility:
- Individuals at least 18 years of age (at least 14 years of age for Phase 1 of the study)
who live in the province of Ogliastra in eastern Sardinia.
Design:
- This 10-year study will involve three phases: collecting initial blood samples and
medical history (years 1 to 4), and two sets of follow-up visits to collect additional
data (3 years apart).
- Participants will provide detailed medical history and information for long-term study,
primarily involving the following aspects:
- Demographic/family and clinical variables (e.g., medications, fertility,
hospitalizations and surgical procedures, age of relatives who are still alive, age and
cause of death in deceased relatives) (Phase 1)
- Complete physical examination, including measures of height and weight, blood pressure,
and basic heart function (Phase 1)
- Blood and urine samples (Phase 1)
- Heart and lung function tests (Phase 1)
- Assessment of general personality traits and possible history of depression (Phase 1)
- Dietary assessment through a food frequency questionnaire (Phase 1)
- Cognitive tests of attention, memory, and concentration (Phases 1 and 2)
- Frailty-related tests (e.g., hand grip strength, walking speed, bone strength) (Phases 1
and 2)
- Eye examination to test for evidence of disease or macular degeneration (Phases 1 and 2)
- Kidney and thyroid ultrasound (Phases 1, 2, and 3)
Status | Completed |
Enrollment | 6926 |
Est. completion date | January 2, 2015 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years and older |
Eligibility |
- INCLUSION CRITERIA: The targeted region for the studies, Ogliastra, is an isolated population of 300,000 in an area enclosed by two mountain ranges and the sea. We will recruit from the 8,500 residents in the towns of Lanusei (the capital of the region), Arzana, Elini and Ilbono, independent of their health status. EXCLUSION CRITERIA: At baseline, individuals less than 14 years of age will be excluded from study enrollment. Over the following visits, only individuals 18 and over will be evaluated. |
Country | Name | City | State |
---|---|---|---|
Italy | Italian National Research Council Institute of Neurogenetics and Neuropharmacolo | Lanusei |
Lead Sponsor | Collaborator |
---|---|
National Institute on Aging (NIA) |
Italy,
Liao D, Arnett DK, Tyroler HA, Riley WA, Chambless LE, Szklo M, Heiss G. Arterial stiffness and the development of hypertension. The ARIC study. Hypertension. 1999 Aug;34(2):201-6. — View Citation
Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. Review. — View Citation
Vaitkevicius PV, Fleg JL, Engel JH, O'Connor FC, Wright JG, Lakatta LE, Yin FC, Lakatta EG. Effects of age and aerobic capacity on arterial stiffness in healthy adults. Circulation. 1993 Oct;88(4 Pt 1):1456-62. — View Citation
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