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Clinical Trials in Belgium / NCT04993482
Recruiting Observational

24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients

NCT04993482 · tracked via the Priya Life Science Belgium tracker
Phase
Observational
Started
2021-08-29
Last updated
2023-12-08

Condition(s) studied

Diabetes Mellitus, Type 2

Investigational drug(s) / intervention(s)

No intervention

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.

Study 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) subdivided into light physical activity (LPA) and moderate to vigorous physical activity (MVPA), have shown an impact on T2DM disease-specific characteristics (e.g. glycemic control). However, these behaviors have often been investigated separately. Therefore, a recent shift in research emphasizes the importance of considering these behaviors as part of a 24-hour day.

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Ghent University Hospital, Dept. of Endocrinology Ghent Belgium Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04993482 on ClinicalTrials.gov ↗ ← All trials in Belgium