Aging; Without Mention of PsychosisNCT01480037
Genetic and Physiological Aspects of Oxidative Profile in Sleep and Well-succeed Aging
An observational study of Aging; Without Mention of Psychosis, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
Trial summary
The present study proposes the characterization of sleep patterns of healthy young adults, elderly individuals and individuals above 85 years old, using polysomnographic recordings, in order to clarify the importance of sleep in longevity. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Aging; Without Mention of Psychosis
- How many people
- 38 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Feb 2013
- 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 20 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents of São Paulo city, Brazil
Who may be able to join
- men aged between 20-30 years-old,
- 60-70 years-old and above 90 years-old
Who cannot join
- Uncontrolled chronic disease (cancer, cardiopathy, type 2 diabetes)
- neurological and/or psychiatric antecedents
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Associação Fundo de Incentivo à Pesquisa
São Paulo, São Paulo, 04024002
About this study
The present study proposes the characterization of sleep patterns of healthy young adults, elderly individuals and individuals above 85 years old, using polysomnographic recordings, in order to clarify the importance of sleep in longevity. Furthermore, this study intends to analyze the oxidative stress-related gene expression in peripheral blood of the three studied groups, using the Superarray - RT2 Profiler" PCR Array System. After the identification of genes whose expression pattern among groups suggest a more specific role in longevity, the mechanisms of gene expression regulation, including DNA methylation patterns and microRNA expression, as well as the possible genomic sources of variation in these genes will be investigated. In addition, the oldest individual (105 years-old) will have his whole genome sequenced using next-generation sequencing technology, in order to identify rare variants associated with longevity. Subsequently, the effect of the polymorphisms and rare variants identified will be confirmed in an expanded sample constituted of individuals with various age-ranges. The study will provide a better characterization of molecular and physiological mechanisms involved in longevity, hoping to contribute to the development of more advanced clinical tools, capable to offer a better quality of life for the elderly.
Read the detailed description
In the last decades, the increase in life expectancy highlights the world population aging as an irreversible process. The oxidative stress hypothesis of aging suggests that accumulation of oxidative damage during lifespan may be related to loss of cellular functions, a process normally associated with senescence. However, it has been proposed that individuals who live longer in a successful manner tend to be more adapted against aging physiological changes. Sleep is essential in maintaining health and well-being. Growing evidence suggests interrelationships between oxidative stress and sleep, while the latter is an important mechanism involved in redox balance maintenance. Therefore, the present study proposes the characterization of sleep patterns of healthy young adults, elderly individuals and individuals above 85 years old, using polysomnographic recordings, in order to clarify the importance of sleep in longevity. Furthermore, this study intends to analyze the oxidative stress-related gene expression in peripheral blood of the three studied groups, using the Superarray - RT2 Profiler" PCR Array System. After the identification of genes whose expression pattern among groups suggest a more specific role in longevity, the mechanisms of gene expression regulation, including DNA methylation patterns and microRNA expression, as well as the possible genomic sources of variation in these genes will be investigated. In addition, the oldest individual (105 years-old) will have his whole genome sequenced using next-generation sequencing technology, in order to identify rare variants associated with longevity. Subsequently, the effect of the polymorphisms and rare variants identified will be confirmed in an expanded sample constituted of individuals with various age-ranges. The study will provide a better characterization of molecular and physiological mechanisms involved in longevity, hoping to contribute to the development of more advanced clinical tools, capable to offer a better quality of life for the elderly.
- Conditions
- Aging; Without Mention of Psychosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elderly | Individuals between 60 and 70 years-old | |
| Long-lived | Individuals above 85 years-old | |
| Young | Individuals between 20 and 30 years-old |
What is being measured
The primary outcome is the main question the study is designed to answer.
Polysomnography parameters
Measured: 1 night
Gene expression data
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study startMar 2010
- Primary completionJun 2011
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging; Without Mention of PsychosisStudies 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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Associação Fundo de Incentivo à Pesquisa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diego Robles Mazzotti, Associação Fundo de Incentivo à Pesquisa
- Investigators
- Sergio Tufik, MD PhD, Study director, Associação Fundo de Incentivo à Pesquisa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480037
- Sponsor's protocol ID
- LONG-2011
- Status last verified
- Jan 2015
- First submitted
- 23 Nov 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Physiological Aspects of Oxidative Profile in Sleep and Well-succeed Aging
- ClinicalTrials.gov ID
- NCT01480037
- Acronym / sponsor ID
- LONG-2011
- Conditions
- Aging; Without Mention of Psychosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Associação Fundo de Incentivo à PesquisaUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 28 Nov 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.
The present study proposes the characterization of sleep patterns of healthy young adults, elderly individuals and individuals above 85 years old, using polysomnographic recordings, in order to clarify the importance of sleep in longevity. Furthermore, this study intends to analyze the oxidative stress-related gene expression in peripheral blood of the three studied groups, using the Superarray - RT2 Profiler" PCR Array System. After the identification of genes whose expression pattern among groups suggest a more specific role in longevity, the mechanisms of gene expression regulation, including DNA methylation patterns and microRNA expression, as well as the possible genomic sources of variation in these genes will be investigated. In addition, the oldest individual (105 years-old) will have his whole genome sequenced using next-generation sequencing technology, in order to identify rare variants associated with longevity. Subsequently, the effect of the polymorphisms and rare variants identified will be confirmed in an expanded sample constituted of individuals with various age-ranges. The study will provide a better characterization of molecular and physiological mechanisms involved in longevity, hoping to contribute to the development of more advanced clinical tools, capable to offer a better quality of life for the elderly.
Detailed description
In the last decades, the increase in life expectancy highlights the world population aging as an irreversible process. The oxidative stress hypothesis of aging suggests that accumulation of oxidative damage during lifespan may be related to loss of cellular functions, a process normally associated with senescence. However, it has been proposed that individuals who live longer in a successful manner tend to be more adapted against aging physiological changes. Sleep is essential in maintaining health and well-being. Growing evidence suggests interrelationships between oxidative stress and sleep, while the latter is an important mechanism involved in redox balance maintenance. Therefore, the present study proposes the characterization of sleep patterns of healthy young adults, elderly individuals and individuals above 85 years old, using polysomnographic recordings, in order to clarify the importance of sleep in longevity. Furthermore, this study intends to analyze the oxidative stress-related gene expression in peripheral blood of the three studied groups, using the Superarray - RT2 Profiler" PCR Array System. After the identification of genes whose expression pattern among groups suggest a more specific role in longevity, the mechanisms of gene expression regulation, including DNA methylation patterns and microRNA expression, as well as the possible genomic sources of variation in these genes will be investigated. In addition, the oldest individual (105 years-old) will have his whole genome sequenced using next-generation sequencing technology, in order to identify rare variants associated with longevity. Subsequently, the effect of the polymorphisms and rare variants identified will be confirmed in an expanded sample constituted of individuals with various age-ranges. The study will provide a better characterization of molecular and physiological mechanisms involved in longevity, hoping to contribute to the development of more advanced clinical tools, capable to offer a better quality of life for the elderly.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Elderly | – | –Individuals between 60 and 70 years-old |
| Long-lived | – | –Individuals above 85 years-old |
| Young | – | –Individuals between 20 and 30 years-old |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents of São Paulo city, Brazil
Key inclusion criteria (2 listed)
- men aged between 20-30 years-old,
- 60-70 years-old and above 90 years-old
Key exclusion criteria (2 listed)
- Uncontrolled chronic disease (cancer, cardiopathy, type 2 diabetes)
- neurological and/or psychiatric antecedents
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
Polysomnography parameters
Time frame: 1 night
Gene expression data
Time frame: 1 day
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 14 Jan 2015.
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.
Sergio Tufik, MD PhD study director
Associação Fundo de Incentivo à Pesquisa
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 Aging; Without Mention of Psychosis, run by Associação Fundo de Incentivo à Pesquisa at 1 site in Brazil.
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 2 inclusion and 2 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 14 Jan 2015. 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 Brazil. 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.
What does the primary outcome measure?
Polysomnography parameters (time frame: 1 night). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2015.