- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01480037
Genetic and Physiological Aspects of Oxidative Profile in Sleep and Well-succeed Aging
January 13, 2015 updated by: Diego Robles Mazzotti, Associação Fundo de Incentivo à Pesquisa
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 Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
38
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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São Paulo, Brazil, 04024002
- Associação Fundo de Incentivo à Pesquisa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Residents of São Paulo city, Brazil
Description
Inclusion Criteria:
- men aged between 20-30 years-old,
- 60-70 years-old and above 90 years-old
Exclusion Criteria:
- Uncontrolled chronic disease (cancer, cardiopathy, type 2 diabetes)
- neurological and/or psychiatric antecedents
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Polysomnography parameters
Time Frame: 1 night
|
1 night
|
|
Gene expression data
Time Frame: 1 day
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Sergio Tufik, MD PhD, Associação Fundo de Incentivo à Pesquisa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
June 1, 2011
Study Completion (Actual)
February 1, 2013
Study Registration Dates
First Submitted
November 23, 2011
First Submitted That Met QC Criteria
November 25, 2011
First Posted (Estimate)
November 28, 2011
Study Record Updates
Last Update Posted (Estimate)
January 14, 2015
Last Update Submitted That Met QC Criteria
January 13, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LONG-2011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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