Heart DiseaseNCT00182949
Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population
An observational study of Heart Disease and Physical Frailty, run by National Institute on Aging (NIA) at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Disease, Physical Frailty, Exaggerated Personality Traits
- How many people
- 6,926 participants
- Where
- 1 siteItaly
- Study dates
- 19 Nov 2003to 2 Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Italian National Research Council Institute of Neurogenetics and Neuropharmacolo
Lanusei
About this study
Official title: Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population (SARDINIA)
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.
Read more
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)
Read the detailed description
The 1,500,000 people of the island of Sardinia arose from a much smaller number, starting thousands of years ago, with very little immigration from outside during that entire period. SardiNIA is a longitudinal study designed under the assumption that in highly interrelated population, such as the Sardinians, discovering the genetic factors that predispose individuals to disease and to other physiological characteristics is easier and more cost-effective. Thus far, group of 6,148 participants from a cluster of 4 towns in the Ogliastra region (Lanusei, Ilbono, Elini, and Arzana) has been assessed for about 100 quantitative traits, including a range of traits related to heart disease, features of personality, frailty, cognition and several blood tests (see Table 1). The DNA from all participants has been analyzed (genotyped) to look for variants of genes that are involved in determining the traits. Up to now, at least one gene has been discovered for each trait, including genes specific for levels of uric acid, fetal hemoglobin, cholesterol, etc. The analyses of genes are continuing, and are being extended to additional traits In addition, to improve the longitudinal perspective of the study, participants will be followed to detect the development on new health-related events or outcomes . This is done in 3 ways: 1) looking at genetic factors determining rates of change of levels of traits like blood pressure with age, based on repeated measures in currently ongoing second visits and planned third visits; 2) seeing which participants do or do not contract particular diseases, to test whether the genes discovered that affect risk factors can help to predict related health problems; and 3) comparing the DNA of disease-free participants in the study to DNA from Sardinian patients affected by particular diseases, to see if the genes already found or additional ones uncovered by the comparisons are involved in those diseases By looking at the development of outcomes, the SardiNIA project (called ProgeNIA for the population) further improves our understanding of the genetic factors involved in age-associated diseases and disorders. Those genes may then provide possible points of intervention that may yield routes to prevention of the diseases.
- Keywords
- Epidemiology, Genetics, Aging, Sardinian Population, Cardiovascular Diseases, Personality Traits, Frailty
- Medical subject headings
- Heart Diseases, Cardiovascular Diseases, Frailty
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study start19 Nov 2003
- Study completion2 Jan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 6,926 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David A Schlessinger, Ph.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00182949
- Sponsor's protocol ID
- 999904317
- Other IDs
- 04-AG-N317
- Status last verified
- 2 Jan 2015
- First submitted
- 13 Sep 2005
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.
PubMed 10866211Liao 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. doi: 10.1161/01.hyp.34.2.201.
PubMed 10454441Vaitkevicius 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. doi: 10.1161/01.cir.88.4.1456.
PubMed 8403292
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population (SARDINIA)
- ClinicalTrials.gov ID
- NCT00182949
- Acronym / sponsor ID
- 999904317
- Keywords
- Epidemiology, Genetics, Aging, Sardinian Population, Cardiovascular Diseases, Personality Traits, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,926 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 19 Nov 2003
- Study completion
- 2 Jan 2015
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed description
The 1,500,000 people of the island of Sardinia arose from a much smaller number, starting thousands of years ago, with very little immigration from outside during that entire period. SardiNIA is a longitudinal study designed under the assumption that in highly interrelated population, such as the Sardinians, discovering the genetic factors that predispose individuals to disease and to other physiological characteristics is easier and more cost-effective. Thus far, group of 6,148 participants from a cluster of 4 towns in the Ogliastra region (Lanusei, Ilbono, Elini, and Arzana) has been assessed for about 100 quantitative traits, including a range of traits related to heart disease, features of personality, frailty, cognition and several blood tests (see Table 1). The DNA from all participants has been analyzed (genotyped) to look for variants of genes that are involved in determining the traits. Up to now, at least one gene has been discovered for each trait, including genes specific for levels of uric acid, fetal hemoglobin, cholesterol, etc. The analyses of genes are continuing, and are being extended to additional traits In addition, to improve the longitudinal perspective of the study, participants will be followed to detect the development on new health-related events or outcomes . This is done in 3 ways: 1) looking at genetic factors determining rates of change of levels of traits like blood pressure with age, based on repeated measures in currently ongoing second visits and planned third visits; 2) seeing which participants do or do not contract particular diseases, to test whether the genes discovered that affect risk factors can help to predict related health problems; and 3) comparing the DNA of disease-free participants in the study to DNA from Sardinian patients affected by particular diseases, to see if the genes already found or additional ones uncovered by the comparisons are involved in those diseases By looking at the development of outcomes, the SardiNIA project (called ProgeNIA for the population) further improves our understanding of the genetic factors involved in age-associated diseases and disorders. Those genes may then provide possible points of intervention that may yield routes to prevention of the diseases.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 10866211Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.
- Background: PubMed 10454441Liao 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. doi: 10.1161/01.hyp.34.2.201.
- Background: PubMed 8403292Vaitkevicius 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. doi: 10.1161/01.cir.88.4.1456.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David A Schlessinger, Ph.D. principal investigator
National Institute on Aging (NIA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Disease and Physical Frailty, run by National Institute on Aging (NIA) at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00182949, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2018.