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Estudo Longitudinal de Saúde do Adulto (Brazilian Longitudinal Study of Adult Health ) (ELSA-Brasil)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02320461
Recruitment Status : Unknown
Verified December 2014 by MSchmidt, Federal University of Rio Grande do Sul.
Recruitment status was:  Active, not recruiting
First Posted : December 19, 2014
Last Update Posted : December 19, 2014
Sponsor:
Information provided by (Responsible Party):
MSchmidt, Federal University of Rio Grande do Sul

Study Description
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Brief Summary:

The Brazilian Longitudinal Study of Adult Health (ELSA-Brasil) aims to contribute with relevant information regarding the development and progression of clinical and subclinical chronic diseases, particularly cardiovascular diseases and diabetes. The investigators enrolled 15,105 civil servants from predefined universities or research institutes. Baseline assessment (2008-2010) included detailed interviews and measurements to assess social and biological determinants of health, as well as various clinical and subclinical conditions related to diabetes, cardiovascular diseases and mental health. For the ascertainment of incident events, annual telephone surveillance is being conducted since 2009, and a second visit of interviews and exams is under way (2012-2014). Long-term biological sample storage is provided for sera, plasma, urine and DNA. Baseline data is available for analyses, and collaboration via specific research proposals directed to study investigators is welcome.

This multicenter study is chaired by a steering committee, made up of the coordinators and vice-coordinators of each of the six centers. No individual center coordinates the study. The six institutions listed in the contact details all sponsor the study.


Condition or disease
Diabetes Mellitus Cardiovascular Diseases

Detailed Description:
Full details of the study have been published in the American Journal of Epidemiology (http://aje.oxfordjournals.org/content/early/2012/01/10/aje.kwr294.full) and the International Journal of Epidemiology (http://ije.oxfordjournals.org/content/early/2014/02/27/ije.dyu027.abstract), as listed in the References here. Both articles are available in full text for download without charge.
Study Design
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Study Type : Observational
Actual Enrollment : 15105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estudo Longitudinal de Saúde do Adulto
Study Start Date : August 2008
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Diabetes mellitus (Incident cases) [ Time Frame: 6 years ]
    Incident cases

  2. Myocardial infarction (Incident cases) [ Time Frame: 6 years ]
    Incident cases


Biospecimen Retention:   Samples With DNA
Frozen serum and urine samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
ELSA-Brasil is a cohort study of 15,105 civil servants. All active or retired employees of the six institutions (and, in a few instances, also of related educational or health institutions), of both sexes, and with ages between 35 and 74 years, were eligible for the study. The six institutions, located in three different Brazilian regions, are: the Federal Universities of Bahia, Espirito Santo, Minas Gerais and Rio Grande do Sul, the University of Sao Paulo and the Oswaldo Cruz Foundation.
Criteria

Inclusion Criteria:

  • age 35-74 years,
  • active or retired employees of the institutions involved or affiliated institutions.

Exclusion Criteria:

  • current or recent (<4 months prior to the first interview) pregnancy,
  • intention to quit work at the institution in the near future,
  • severe cognitive or communication impairment and,
  • if retired, residence outside each center´s corresponding metropolitan area.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02320461


Sponsors and Collaborators
Federal University of Rio Grande do Sul
Investigators
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Principal Investigator: Estela M Aquino, MD Federal University of Bahia
Principal Investigator: José G Mill, MD Federal University of Espirito Santo
Principal Investigator: Sandhi M Barreto, MD Universidade Federal da Minas Gerais
Principal Investigator: Rosane H Griep, DSc Fundação Oswaldo Cruz
Principal Investigator: Paulo A Lotufo, MD University of Sao Paulo
Principal Investigator: Maria I Schmidt, MD Federal University of Rio Grande do Sul
More Information
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Additional Information:

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: MSchmidt, Associate Professor, Federal University of Rio Grande do Sul
ClinicalTrials.gov Identifier: NCT02320461    
Other Study ID Numbers: 01.06.0010.00
First Posted: December 19, 2014    Key Record Dates
Last Update Posted: December 19, 2014
Last Verified: December 2014
Keywords provided by MSchmidt, Federal University of Rio Grande do Sul:
diabetes mellitus
cardiovascular diseases
cohort studies
hypertension
 obesity
smoking
social class
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases