Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)
Bicycling and Mortality Among Individuals With Diabetes in the European Prospective Investigation Into Cancer and Nutrition (EPIC)
Přehled studie
Detailní popis
AIMS The primary aim of the study is to study the relationship between overall bicycling and all-cause mortality and secondarily cardiovascular disease mortality among individuals with diabetes from European countries. A secondary aim will be to study the relation of change in bicycling to all-cause mortality and cardiovascular disease mortality.
METHODS Study design and setting The study is a nested cohort study in European Prospective Investigation into Cancer and Nutrition (EPIC) cohort. In EPIC, 29 centers in 10 western European countries have collected information on nutrition, lifestyle, anthropometrics and medical history from more than 521 000 study individuals participating in this prospective cohort study. Dietary, medical history and lifestyle were assessed by questionnaires. Blood samples from the participants were taken at the study centers. Baseline (first examination) information was collected 1992-2000 and second examination for exposure has since been obtained at least once in every cohort. Exposure data has subsequently, to the two examinations, been linked to information on vital status and on cause of death were obtained through record linkages with national, regional or local registers, regional health departments, physicians or hospitals, active follow-up or health insurance.
Study population This nested prospective cohort study, sampled individuals with prevalent diabetes in the EPIC cohorts at the baseline assessments in the years 1992-2000. Self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin>=6.0%, five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses. No information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison. The nested cohort for this study comprised 12,848 individuals with self-reported and/or confirmed diabetes. Mean (SD) follow-up time was 14.6 (4.8) years. Among the 12,848 prevalent diabetes cases, 5,809 cases were confirmed at baseline as described above.
For further detail, please see the predefined statistical analysis plan (SAP). It can be accessed through the url: http://aktivsundhed.dk/images/docs/SAPMRL.pdf
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní místa
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Copenhagen, Dánsko, 2100
- Center for Physical Activity Research, Copenhagen University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
Inclusion Criteria:
- Confirmed or self-reported diabetes at first examination
Exclusion Criteria:
- None
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
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Patients with diabetes at the baseline assessement in EPIC
Self-reported and confirmed diabetes (validated by a second source (at least 1), including repeated self-report, contact with physician, linkage to register later point, intake of diabetes medicine, registration of diabetic chiropody, baseline glycated hemoglobin>=6.0%,
five annual blood glucose measurements or two blood glucose measurements per year for five consecutive years) cases were included in the analyses.
No information is available to distinguish between type 1 and type 2 diabetes across the population but type 1 is rare by comparison.
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Total bicycling is reported in categories of: (0 - reference), (>0 to <60), (≤60 to >150), (≤150 to < 300) and (≥300) minutes/week
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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All-cause Mortality
Časové okno: From 0 years and up to 17 years or until death from any cause, whichever comes first.
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0 (Alive at follow-up) or 1 (Death at follow-up)
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From 0 years and up to 17 years or until death from any cause, whichever comes first.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Cause specific mortality: Cardiovascular
Časové okno: From 0 years and up to 17 years or until death from any cause, whichever comes first.
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0 (Alive at follow-up) or 1 (Death at follow-up: cause being International Classification of Diseases, Injuries, and Causes of Death, Tenth Revision, I00-I99 )
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From 0 years and up to 17 years or until death from any cause, whichever comes first.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Cause specific mortality: Cardiovascular
Časové okno: From 4-6 years (second examination) after 0 years (first examination) and up to 12 years or until death from any cause, whichever comes first.
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0 (Alive at follow-up) or 1 (Death at follow-up: cause being International Classification of Diseases, Injuries, and Causes of Death, Tenth Revision, I00-I99 )
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From 4-6 years (second examination) after 0 years (first examination) and up to 12 years or until death from any cause, whichever comes first.
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All-cause Mortality
Časové okno: From 4-6 years (second examination) after 0 years (first examination) and up to 12 years or until death from any cause, whichever comes first.
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0 (Alive at follow-up) or 1 (Death at follow-up)
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From 4-6 years (second examination) after 0 years (first examination) and up to 12 years or until death from any cause, whichever comes first.
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Mathias Ried-Larsen, PhD, Copenhagen University Hospital, Centre for Physical Activity Research
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Bicycling and Diabetes (17-25)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Request for individual patient data should be directed to the International Agency for Research on Cancer (IARC)
The predefined statistical analyses plan is available (see link)
Studijní data/dokumenty
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Plán statistické analýzy
Komentáře k informacím: Pre-defined statistical analysis plan. Published on Centre for Physical Activity Research prior to commencing the analyses.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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