Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00182949
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2005-09-13
Brief Title:
Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population
Sponsor:
National Institute on Aging NIA
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Genetics and Epidemiology of Aging Associated Conditions in the Sardinian Population SARDINIA
Status:
COMPLETED
Status Verified Date:
2015-01-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
Demographicfamily and clinical variables eg 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 eg 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
- 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
Demographicfamily and clinical variables eg 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 eg 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 1500000 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 6148 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-AG-N317 | None | None | None |