Clinical trial NCT04993482: 24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
Official title: 24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes Mellitus, Type 2
Keywords: physical activity
sedentary behavior
sleep
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: University Ghent
First posted: 2021-08-06
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The main focus of this project is to explore 24-hour movement behavior among type 2 diabetes mellitus patients. However, the control group will be included because of lacking evidence on the 24-hour movement pattern in the general Belgian population.

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) 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.

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 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

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

Primary outcomes:
measure: Change in 24-hour movement composition from baseline over one year and two-year follow-up
timeFrame: Baseline
measure: Change in 24-hour movement composition from baseline over one year and two-year follow-up
timeFrame: The same primary outcome will be collected after one year
measure: Change in 24-hour movement composition from baseline over one year and two-year follow-up
timeFrame: The same primary outcome will be collected after two years
Secondary outcomes:
measure: Change in HbA1c from baseline to two-year follow-up
timeFrame: baseline
measure: Change in HbA1c from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
timeFrame: baseline
measure: Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in triglycerides from baseline to two-year follow-up
timeFrame: Baseline
measure: Change in triglycerides from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in insulin from baseline to two-year follow-up
timeFrame: Baseline
measure: Change in insulin from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in glucose from baseline to two-year follow-up
timeFrame: Baseline
measure: Change in glucose from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
timeFrame: Baseline
measure: Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
timeFrame: baseline
measure: Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after one year
measure: Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in waist circumference from baseline to one and two-year follow-up
timeFrame: Baseline
measure: Change in waist circumference from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after one year
measure: Change in waist circumference from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
timeFrame: baseline
measure: Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after one year
measure: Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
measure: Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
timeFrame: baseline
measure: Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after one year
measure: Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
timeFrame: The same secondary outcome will be collected after two years
Other outcomes:
measure: Explanatory variables: change in demographics from baseline to one and two-year follow-up
timeFrame: baseline
measure: Explanatory variables: change in demographics from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: change in demographics from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after two years
measure: Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
timeFrame: baseline
measure: Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: change in dietary factors from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after two years
measure: Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
timeFrame: baseline
measure: Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: change in quality of Life (QoL) from baseline to one and two-year follow-up
timeFrame: The same explanatory outcome will be collected after two years
measure: Explanatory variables: Behavioral factors
timeFrame: baseline
measure: Explanatory variables: Behavioral factors
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: Behavioral factors
timeFrame: The same explanatory outcome will be collected after two years
measure: Explanatory variables: socio-environmental factors
timeFrame: baseline
measure: Explanatory variables: socio-environmental factors
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: socio-environmental factors
timeFrame: The same explanatory outcome will be collected after two years
measure: Explanatory variables: physical environmental factors
timeFrame: baseline
measure: Explanatory variables: physical environmental factors
timeFrame: The same explanatory outcome will be collected after one year
measure: Explanatory variables: physical environmental factors
timeFrame: The same explanatory outcome will be collected after two years
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital, Dept. of Endocrinology
Study officials:
affiliation: Ghent University Hospital - endocrinologist
name: Bruno Lapauw, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University Ghent
name: Marieke De Craemer, Professor
role: PRINCIPAL_INVESTIGATOR
References: