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)
연구 개요
상세 설명
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
연구 유형
등록 (예상)
연락처 및 위치
연구 장소
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Copenhagen, 덴마크, 2100
- Center for Physical Activity Research, Copenhagen University Hospital
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Confirmed or self-reported diabetes at first examination
Exclusion Criteria:
- None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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All-cause Mortality
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cause specific mortality: Cardiovascular
기간: 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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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cause specific mortality: Cardiovascular
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Mathias Ried-Larsen, PhD, Copenhagen University Hospital, Centre for Physical Activity Research
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- Bicycling and Diabetes (17-25)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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)
연구 데이터/문서
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통계 분석 계획
정보 댓글: Pre-defined statistical analysis plan. Published on Centre for Physical Activity Research prior to commencing the analyses.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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