Status:
RECRUITING
24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
Lead Sponsor:
University Hospital, Ghent
Collaborating Sponsors:
University Ghent
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-100 years
Brief Summary
A healthy lifestyle has proved beneficial health effects in managing type 2 diabetes mellitus (T2DM). Important lifestyle behaviors, i.e. sleep, sedentary time (SB), and physical activity (PA) subdivi...
Detailed Description
The present study aims (1) to conduct a longitudinal observational study over two years to explore 24-hour movement behavior composition patterns among T2DM patients in comparison with a healthy contr...
Eligibility Criteria
Inclusion criteria T2DM patients
- Adults aged >18 years old
- Diagnosed with T2DM by a physician or an HbA1C above 6.5%
Exclusion criteria T2DM patients
- Diagnosed with type 1 diabetes mellitus (T1DM)
- Diagnosed with pregnancy diabetes
- Diagnosed with latent autoimmune diabetes in adults (LADA)
- Physical disabilities that obstruct the normal PA pattern (e.g. amputations, paralysis)
- Cognitive disabilities that obstruct daily functioning (e.g. dementia, psychological disorders)
- Other conditions affecting the normal PA pattern (e.g. heart failure NYHA class 3 and 4, chronic respiratory diseases (COPD stage 4), end stage nonalcoholic fatty liver disease, end stage renal failure, cancer, hospitalized)
- Pregnancy or pregnancy <1 year ago
- Participating in a physical activity intervention
Inclusion criteria control participants
- Adults aged > 18 years old
Exclusion criteria control participants
- Diagnosed with T2DM
- Diagnosed with T1DM
- Diagnosed with pregnancy diabetes
- Diagnosed with LADA
- Physical disabilities that obstruct the normal PA pattern (e.g. amputations, paralysis)
- Cognitive disabilities that obstruct daily functioning (e.g. dementia, psychological disorders)
- Other conditions affecting the normal PA pattern (e.g. heart failure NYHA class 3 and 4, chronic respiratory diseases (COPD stage 4), end stage nonalcoholic fatty liver disease, end stage renal failure, cancer, hospitalized)
- Pregnancy or pregnancy <1 year ago
- Participating in a physical activity intervention
Key Trial Info
Start Date :
August 29 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT04993482
Start Date
August 29 2021
End Date
December 1 2026
Last Update
December 8 2023
Active Locations (1)
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1
Ghent University Hospital, Dept. of Endocrinology
Ghent, Belgium, 9000