NCT02320461

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.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
15,105

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2008

Longer than P75 for all trials

Status
unknown

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

August 1, 2008

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

December 16, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 19, 2014

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

December 19, 2014

Status Verified

December 1, 2014

Enrollment Period

12.3 years

First QC Date

December 16, 2014

Last Update Submit

December 18, 2014

Conditions

Keywords

diabetes mellituscardiovascular diseasescohort studieshypertensionobesitysmokingsocial class

Outcome Measures

Primary Outcomes (2)

  • Diabetes mellitus (Incident cases)

    Incident cases

    6 years

  • Myocardial infarction (Incident cases)

    Incident cases

    6 years

Eligibility Criteria

Age35 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Aquino EM, Barreto SM, Bensenor IM, Carvalho MS, Chor D, Duncan BB, Lotufo PA, Mill JG, Molina Mdel C, Mota EL, Passos VM, Schmidt MI, Szklo M. Brazilian Longitudinal Study of Adult Health (ELSA-Brasil): objectives and design. Am J Epidemiol. 2012 Feb 15;175(4):315-24. doi: 10.1093/aje/kwr294. Epub 2012 Jan 10.

    PMID: 22234482BACKGROUND
  • Schmidt MI, Duncan BB, Mill JG, Lotufo PA, Chor D, Barreto SM, Aquino EM, Passos VM, Matos SM, Molina Mdel C, Carvalho MS, Bensenor IM. Cohort Profile: Longitudinal Study of Adult Health (ELSA-Brasil). Int J Epidemiol. 2015 Feb;44(1):68-75. doi: 10.1093/ije/dyu027. Epub 2014 Feb 27.

    PMID: 24585730BACKGROUND
  • Birck MG, Almeida-Pititto B, Janovsky CCPS, Goulart AC, Santos IS, Teixeira PFDS, Sgarbi JA, Barreto SM, Duncan BB, Schmidt MI, Lotufo PA, Bensenor IM. Thyroid-Stimulating Hormone and Thyroid Hormones and Incidence of Diabetes: Prospective Results of the Brazilian Longitudinal Study of Adult Health (ELSA-BRASIL). Thyroid. 2022 Jun;32(6):694-704. doi: 10.1089/thy.2021.0533. Epub 2022 May 24.

  • Riboldi BP, Luft VC, Bracco PA, de Oliveira Cardoso L, Molina MDC, Alvim S, Giatti L, Schmidt MI, Duncan BB. The inflammatory food index and its association with weight gain and incidence of diabetes: Longitudinal Study of Adult Health (ELSA-Brasil). Nutr Metab Cardiovasc Dis. 2022 Mar;32(3):675-683. doi: 10.1016/j.numecd.2021.12.022. Epub 2022 Jan 6.

  • Drehmer M, Odegaard AO, Schmidt MI, Duncan BB, Cardoso LO, Matos SMA, Molina MDCB, Barreto SM, Pereira MA. Brazilian dietary patterns and the dietary approaches to stop hypertension (DASH) diet-relationship with metabolic syndrome and newly diagnosed diabetes in the ELSA-Brasil study. Diabetol Metab Syndr. 2017 Feb 13;9:13. doi: 10.1186/s13098-017-0211-7. eCollection 2017.

  • Drehmer M, Pereira MA, Schmidt MI, Del Carmen B Molina M, Alvim S, Lotufo PA, Duncan BB. Associations of dairy intake with glycemia and insulinemia, independent of obesity, in Brazilian adults: the Brazilian Longitudinal Study of Adult Health (ELSA-Brasil). Am J Clin Nutr. 2015 Apr;101(4):775-82. doi: 10.3945/ajcn.114.102152. Epub 2015 Jan 21.

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Frozen serum and urine samples

MeSH Terms

Conditions

Diabetes MellitusCardiovascular DiseasesHypertensionObesitySmoking

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 16, 2014

First Posted

December 19, 2014

Study Start

August 1, 2008

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

December 19, 2014

Record last verified: 2014-12