24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients

Ghent University Hospital (UZ)

Status

Enrolling

Conditions

Diabetes Mellitus, Type 2

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04993482

BC-10189

Details and patient eligibility

About

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.

Full 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 control group and (2) to examine associations between these movement behaviors and personal and environmental determinants, and cardiometabolic markers. This study's primary endpoint is to develop insights into the 24-hour movement composition combined with T2DM patients' characteristics, determinants, and health profile to set the groundwork with the aim to develop, implement and evaluate an intervention in a future randomized controlled trial

Enrollment

248 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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