NCT01480037

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2010

Typical duration 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

March 1, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 28, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

January 14, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

November 23, 2011

Last Update Submit

January 13, 2015

Conditions

Outcome Measures

Primary Outcomes (2)

  • Polysomnography parameters

    1 night

  • Gene expression data

    1 day

Study Arms (3)

Elderly

Individuals between 60 and 70 years-old

Long-lived

Individuals above 85 years-old

Young

Individuals between 20 and 30 years-old

Eligibility Criteria

Age20 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Residents of São Paulo city, Brazil

You may qualify if:

  • men aged between 20-30 years-old,
  • years-old and above 90 years-old

You may not qualify if:

  • Uncontrolled chronic disease (cancer, cardiopathy, type 2 diabetes)
  • neurological and/or psychiatric antecedents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Associação Fundo de Incentivo à Pesquisa

São Paulo, São Paulo, 04024002, Brazil

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected for DNA and RNA extraction, as well as for laboratory examinations

Study Officials

  • Sergio Tufik, MD PhD

    Associação Fundo de Incentivo à Pesquisa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Diego Robles Mazzotti

Study Record Dates

First Submitted

November 23, 2011

First Posted

November 28, 2011

Study Start

March 1, 2010

Primary Completion

June 1, 2011

Study Completion

February 1, 2013

Last Updated

January 14, 2015

Record last verified: 2015-01

Locations