24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
NCT ID: NCT04993482
Last Updated: 2023-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
248 participants
OBSERVATIONAL
2021-08-29
2026-12-01
Brief Summary
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Since T2DM patients can benefit from an optimal 24-hour composition as part of a healthy lifestyle, it may be interesting to investigate the 24-hour movement composition among these T2DM patients over time. Moreover, exploring associations with different personal determinants, environmental determinants, and cardiometabolic markers will provide meaningful insights in developing recommendations and creating an intervention.
Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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type 2 diabetes mellitus group
124 adults with type 2 diabetes mellitus will be included
No intervention
This project contains a longitudinal observational study design. The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years). Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
control group
124 control adults will be included
No intervention
This project contains a longitudinal observational study design. The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years). Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
Interventions
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No intervention
This project contains a longitudinal observational study design. The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years). Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with T2DM by a physician or an HbA1C above 6.5%
\- Adults aged \> 18 years old
Exclusion Criteria
* 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
* 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
18 Years
100 Years
ALL
Yes
Sponsors
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University Ghent
OTHER
University Hospital, Ghent
OTHER
Responsible Party
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Principal Investigators
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Bruno Lapauw, Professor
Role: PRINCIPAL_INVESTIGATOR
Ghent University Hospital - endocrinologist
Marieke De Craemer, Professor
Role: PRINCIPAL_INVESTIGATOR
University Ghent
Locations
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Ghent University Hospital, Dept. of Endocrinology
Ghent, , Belgium
Countries
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Central Contacts
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Facility Contacts
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Bruno Lapauw, MD, PhD
Role: primary
Other Identifiers
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BC-10189
Identifier Type: -
Identifier Source: org_study_id