NCT00182949

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:
  • 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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,926

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 19, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
9.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2015

Completed
Last Updated

April 5, 2018

Status Verified

January 2, 2015

First QC Date

September 13, 2005

Last Update Submit

April 4, 2018

Conditions

Heart DiseasePhysical FrailtyExaggerated Personality Traits

Keywords

EpidemiologyGeneticsAgingSardinian PopulationCardiovascular DiseasesPersonality TraitsFrailty

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Italian National Research Council Institute of Neurogenetics and Neuropharmacolo

Lanusei, Italy

Location

Related Publications (3)

  • Risch NJ. Searching for genetic determinants in the new millennium. Nature. 2000 Jun 15;405(6788):847-56. doi: 10.1038/35015718.

    PMID: 10866211BACKGROUND

  • 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. doi: 10.1161/01.hyp.34.2.201.

    PMID: 10454441BACKGROUND

  • 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. doi: 10.1161/01.cir.88.4.1456.

    PMID: 8403292BACKGROUND

MeSH Terms

Conditions

Heart DiseasesCardiovascular DiseasesFrailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • David A Schlessinger, Ph.D.

    National Institute on Aging (NIA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

November 19, 2003

Study Completion

January 2, 2015

Last Updated

April 5, 2018

Record last verified: 2015-01-02

Locations

IT(1)