AtherosclerosisNCT01322568
Research on Aging Project in Iceland: Second Stage
An observational study of Atherosclerosis and Osteoporosis, run by National Institute on Aging (NIA) at 1 site in Iceland.
Trial summary
Background: Researchers are interested in studying the environmental and genetic factors that play a role in health and living conditions as people age. Since 2002, the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute have been conducting a long-term study known as the Research… Read more about this study
- Who is it for?
- Ages 32 to 60 years
- Conditions the study is for
- Atherosclerosis, Osteoporosis, Obesity
- How many people
- 5,764 participants
- Where
- 1 siteIceland
- Study dates
- 31 Jan 2003to 11 Feb 2014
- 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 32 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Age, Gene/Environment Susceptibility (AGES) Study
Background:
- Researchers are interested in studying the environmental and genetic factors that play a role in health and living conditions as people age. Since 2002, the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute have been conducting a long-term study known as the Research in Aging project to collect personal data and samples from Icelandic men and women in order to study risk factors related to disease and disability in old age. Researchers plan to initiate a second stage of the study.
Read more
Objectives:
- To collect additional personal information, medical records, and blood samples from individuals who have previously provided materials for the Research in Aging Project in Iceland.
Eligibility:
- Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.
Design:
- Participants will have a physical examination with imaging analysis procedures and hearing and eye tests, provide information on health and diet, and provide a 100-ml blood sample for testing.
- Participants will also provide consent for researchers to consult data and samples collected during the first stage of the Research on Aging project.
Read the detailed description
In anticipation of the sequencing of the human genome and description of the human proteome, the Age, Gene/Environment Susceptibility-Reykjavik Study (AGES) was initiated in 2002. AGES was designed to examine risk factors, including genetic susceptibility and gene/environment interaction, in relation to disease and disability in old age. The study is multidisciplinary, providing detailed phenotypes related to the cardiovascular, neurocognitive (including sensory), and musculoskeletal systems, and to body composition and metabolic regulation. Relevant quantitative traits, subclinical indicators of disease, and medical diagnoses are identified by using biomarkers, imaging, and other physiologic indicators. The AGES sample is drawn from an established population-based cohort, the Reykjavik Study. This cohort of men and women born between 1907 and 1935 has been followed in Iceland since 1967 by the Icelandic Heart Association. The AGES cohort, with cardiovascular risk factor assessments earlier in life and detailed late- life phenotypes of quantitative traits, will create a comprehensive study of aging nested in a relatively genetically homogeneous older population. This approach should facilitate identification of genetic factors that contribute to healthy aging as well as the chronic conditions common in old age.
- Conditions
- Atherosclerosis, Osteoporosis, Obesity, Glucose Abnormalities, Alzheimer's Disease, Vascular Dimentia
- Keywords
- Aging, Gene, Environment, Inflammation, Iceland
- Medical subject headings
- Atherosclerosis, Osteoporosis, Obesity, Alzheimer Disease, Inflammation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study start31 Jan 2003
- Study completion11 Feb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- 5,764 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Tamara B Harris, M.D., Principal investigator, National Institute on Aging (NIA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322568
- Sponsor's protocol ID
- 999903319
- Other IDs
- 03-AG-N319
- Status last verified
- 11 Feb 2014
- First submitted
- 23 Mar 2011
- Last updated
- 12 Nov 2019
- Results posted
- No
Publications
Freimer N, Sabatti C. The human phenome project. Nat Genet. 2003 May;34(1):15-21. doi: 10.1038/ng0503-15. No abstract available.
PubMed 12721547Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
PubMed 9887164Ershler WB, Keller ET. Age-associated increased interleukin-6 gene expression, late-life diseases, and frailty. Annu Rev Med. 2000;51:245-70. doi: 10.1146/annurev.med.51.1.245.
PubMed 10774463Schelbert EB, Cao JJ, Sigurdsson S, Aspelund T, Kellman P, Aletras AH, Dyke CK, Thorgeirsson G, Eiriksdottir G, Launer LJ, Gudnason V, Harris TB, Arai AE. Prevalence and prognosis of unrecognized myocardial infarction determined by cardiac magnetic resonance in older adults. JAMA. 2012 Sep 5;308(9):890-6. doi: 10.1001/2012.jama.11089.
PubMed 22948699
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age, Gene/Environment Susceptibility (AGES) Study
- ClinicalTrials.gov ID
- NCT01322568
- Acronym / sponsor ID
- 999903319
- Conditions
- Atherosclerosis, Osteoporosis, Obesity, Glucose Abnormalities, Alzheimer's Disease, Vascular Dimentia
- Keywords
- Aging, Gene, Environment, Inflammation, Iceland
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,764 participants (actual)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- 31 Jan 2003
- Study completion
- 11 Feb 2014
- First posted
- 24 Mar 2011 (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:
- Researchers are interested in studying the environmental and genetic factors that play a role in health and living conditions as people age. Since 2002, the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute have been conducting a long-term study known as the Research in Aging project to collect personal data and samples from Icelandic men and women in order to study risk factors related to disease and disability in old age. Researchers plan to initiate a second stage of the study.
Objectives:
- To collect additional personal information, medical records, and blood samples from individuals who have previously provided materials for the Research in Aging Project in Iceland.
Eligibility:
- Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.
Design:
- Participants will have a physical examination with imaging analysis procedures and hearing and eye tests, provide information on health and diet, and provide a 100-ml blood sample for testing.
- Participants will also provide consent for researchers to consult data and samples collected during the first stage of the Research on Aging project.
Detailed description
In anticipation of the sequencing of the human genome and description of the human proteome, the Age, Gene/Environment Susceptibility-Reykjavik Study (AGES) was initiated in 2002. AGES was designed to examine risk factors, including genetic susceptibility and gene/environment interaction, in relation to disease and disability in old age. The study is multidisciplinary, providing detailed phenotypes related to the cardiovascular, neurocognitive (including sensory), and musculoskeletal systems, and to body composition and metabolic regulation. Relevant quantitative traits, subclinical indicators of disease, and medical diagnoses are identified by using biomarkers, imaging, and other physiologic indicators. The AGES sample is drawn from an established population-based cohort, the Reykjavik Study. This cohort of men and women born between 1907 and 1935 has been followed in Iceland since 1967 by the Icelandic Heart Association. The AGES cohort, with cardiovascular risk factor assessments earlier in life and detailed late- life phenotypes of quantitative traits, will create a comprehensive study of aging nested in a relatively genetically homogeneous older population. This approach should facilitate identification of genetic factors that contribute to healthy aging as well as the chronic conditions common in old age.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 32 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Individuals who have previously participated in the Research in Aging project in association with the U.S. National Institute on Aging and the Icelandic Heart Association Research Institute.
Key exclusion criteria (0 listed)
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 12 Nov 2019.
- Background: PubMed 12721547Freimer N, Sabatti C. The human phenome project. Nat Genet. 2003 May;34(1):15-21. doi: 10.1038/ng0503-15. No abstract available.
- Background: PubMed 9887164Ross R. Atherosclerosis--an inflammatory disease. N Engl J Med. 1999 Jan 14;340(2):115-26. doi: 10.1056/NEJM199901143400207. No abstract available.
- Background: PubMed 10774463Ershler WB, Keller ET. Age-associated increased interleukin-6 gene expression, late-life diseases, and frailty. Annu Rev Med. 2000;51:245-70. doi: 10.1146/annurev.med.51.1.245.
- Derived from this study: PubMed 22948699Schelbert EB, Cao JJ, Sigurdsson S, Aspelund T, Kellman P, Aletras AH, Dyke CK, Thorgeirsson G, Eiriksdottir G, Launer LJ, Gudnason V, Harris TB, Arai AE. Prevalence and prognosis of unrecognized myocardial infarction determined by cardiac magnetic resonance in older adults. JAMA. 2012 Sep 5;308(9):890-6. doi: 10.1001/2012.jama.11089.
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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.
Tamara B Harris, M.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 Atherosclerosis and Osteoporosis, run by National Institute on Aging (NIA) at 1 site in Iceland.
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 0 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 12 Nov 2019. 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 Iceland. 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 NCT01322568, which also lists 4 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 12 Nov 2019.