- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02320461
Estudo Longitudinal de Saúde do Adulto (Brazilian Longitudinal Study of Adult Health ) (ELSA-Brasil)
Estudo Longitudinal de Saúde do Adulto
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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Faktiske)
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Diabetes mellitus (Incident cases)
Tidsramme: 6 years
|
Incident cases
|
6 years
|
Myocardial infarction (Incident cases)
Tidsramme: 6 years
|
Incident cases
|
6 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Estela M Aquino, MD, Federal University of Bahia
- Hovedetterforsker: José G Mill, MD, Federal University of Espirito Santo
- Hovedetterforsker: Sandhi M Barreto, MD, Universidade Federal da Minas Gerais
- Hovedetterforsker: Rosane H Griep, DSc, Fundacao Oswaldo Cruz
- Hovedetterforsker: Paulo A Lotufo, MD, University of Sao Paulo
- Hovedetterforsker: Maria I Schmidt, MD, Federal University of Rio Grande do Sul
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
- 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.
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 01.06.0010.00
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