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Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)

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ClinicalTrials.gov Identifier: NCT04171557
Recruitment Status : Active, not recruiting
First Posted : November 21, 2019
Last Update Posted : January 2, 2020
Sponsor:
Collaborator:
University of Southern Denmark
Information provided by (Responsible Party):
Mathias Ried-Larsen, Rigshospitalet, Denmark

Brief Summary:
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.

Condition or disease Intervention/treatment
Diabete Mellitus Behavioral: Bicycling

Detailed Description:

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

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 12848 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 14 Years
Official Title: Bicycling and Mortality Among Individuals With Diabetes in the European Prospective Investigation Into Cancer and Nutrition (EPIC)
Actual Study Start Date : November 20, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Group/Cohort Intervention/treatment
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.
Behavioral: Bicycling
Total bicycling is reported in categories of: (0 - reference), (>0 to <60), (≤60 to >150), (≤150 to < 300) and (≥300) minutes/week




Primary Outcome Measures :
  1. All-cause Mortality [ Time Frame: From 0 years and up to 17 years or until death from any cause, whichever comes first. ]
    0 (Alive at follow-up) or 1 (Death at follow-up)


Secondary Outcome Measures :
  1. Cause specific mortality: Cardiovascular [ Time Frame: From 0 years and up to 17 years or until death from any cause, whichever comes first. ]
    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 )


Other Outcome Measures:
  1. Cause specific mortality: Cardiovascular [ Time Frame: 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. ]
    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 )

  2. All-cause Mortality [ Time Frame: 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. ]
    0 (Alive at follow-up) or 1 (Death at follow-up)



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
See Statistical Analysis Plan
Criteria

Inclusion Criteria:

  • Confirmed or self-reported diabetes at first examination

Exclusion Criteria:

  • None

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): NCT04171557


Locations
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Denmark
Center for Physical Activity Research, Copenhagen University Hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Southern Denmark
Investigators
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Principal Investigator: Mathias Ried-Larsen, PhD Copenhagen University Hospital, Centre for Physical Activity Research
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Pre-defined statistical analysis plan. Published on Centre for Physical Activity Research prior to commencing the analyses.

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Responsible Party: Mathias Ried-Larsen, Senior Researcher, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT04171557    
Other Study ID Numbers: Bicycling and Diabetes (17-25)
First Posted: November 21, 2019    Key Record Dates
Last Update Posted: January 2, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

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)


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mathias Ried-Larsen, Rigshospitalet, Denmark:
Exercise
Physical Activity
Bicycling
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases