Bicycling and Mortality Among Individuals With diabetesNutrition (EPIC)

NCT04171557 | Unknown

• 1 other identifier: Bicycling and Diabetes (17-25)
• Study Type: observational
• Target: 12,848
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabete Mellitus

Keywords

Exercise; Physical Activity; Bicycling

Outcome Measures

Primary Outcomes (1)

• All-cause Mortality

  0 (Alive at follow-up) or 1 (Death at follow-up)

  From 0 years and up to 17 years or until death from any cause, whichever comes first.

Secondary Outcomes (1)

• Cause specific mortality: Cardiovascular

  From 0 years and up to 17 years or until death from any cause, whichever comes first.

Other Outcomes (2)

• Cause specific mortality: Cardiovascular

  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.

• All-cause Mortality

  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.

Study Arms (1)

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

Interventions

Bicycling BEHAVIORAL

Total bicycling is reported in categories of: (0 - reference), (\>0 to \<60), (≤60 to \>150), (≤150 to \< 300) and (≥300) minutes/week

Patients with diabetes at the baseline assessement in EPIC

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

See Statistical Analysis Plan

You may qualify if:

• Confirmed or self-reported diabetes at first examination

You may not qualify if:

• None

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• University of Southern Denmark: collaborator

Study Sites (1)

Center for Physical Activity Research, Copenhagen University Hospital

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus; Motor Activity

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Mathias Ried-Larsen, PhD

  Copenhagen University Hospital, Centre for Physical Activity Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Researcher

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: November 21, 2019
• Study Start: November 20, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)