24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Other: No intervention
- Registration Number
- NCT04993482
- Lead Sponsor
- University Hospital, Ghent
- 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 248
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description type 2 diabetes mellitus group No intervention 124 adults with type 2 diabetes mellitus will be included control group No intervention 124 control adults will be included
- Primary Outcome Measures
Name Time Method Change in 24-hour movement composition from baseline over one year and two-year follow-up The same primary outcome will be collected after two years During their visit to Ghent University hospital, participants will receive a wGT3X-BT ActiGraph accelerometer that will objectively measure their 24-hour movement behaviors (PA, SB, and sleep). The participants will wear the accelerometer for seven consecutive days. Additionally, this accelerometer data will be supplemented with a diary to validate sleep time and (non)wear time. Furthermore, the individuals will subjectively report on their PA, SB, and sleep (duration and quality) through an online questionnaire based on international standardized PA (IPAQ), SB (SIT-Q-7d), and sleep questionnaires (Munich Chronotype questionnaire, Pittsburg sleep quality index, and Sleep Hygiene Index) (IPAQ, Sit-7Q, Munich Chronotype questionnaire, and Pittsburg sleep quality index, Sleep Hygiene Index). By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
- Secondary Outcome Measures
Name Time Method Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up The same secondary outcome will be collected after two years The HOMA Is a method to quantify insulin resistance and beta-cell function. HOMA-IR and HOMA-B will only be collected within the type 2 diabetes group. The HOMA-IR and HOMA-B will be calculated based on the collected insulin and glucose level by the HOMA2 calculator. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in waist circumference from baseline to one and two-year follow-up The same secondary outcome will be collected after two years The waist circumference and hip circumference will be measured with a measuring tape (Seca 201). Both measurements will be used to calculate the waist-to-hip ratio, i.e. WHR= (waist circumference in cm)/ (hip circumference in cm). By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in HbA1c from baseline to two-year follow-up The same secondary outcome will be collected after two years HbA1C will only be collected within the type 2 diabetes group. This will be collected by an analysis of a fasting blood sample. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up The same secondary outcome will be collected after two years Cholesterol (total, HDL, LDL) will only be collected within the type 2 diabetes group. This will be collected by an analysis of a fasting blood sample. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in triglycerides from baseline to two-year follow-up The same secondary outcome will be collected after two years Triglycerides will only be collected within the type 2 diabetes group. This will be collected by an analysis of a fasting blood sample. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up The same secondary outcome will be collected after two years BMI will be calculated by measuring weight (in kilograms) (Seca 861) and height (in meters) (Seca 213). The weight and height will be used in this formula: BMI (kg/m²)= (weight in kg)/(height in m)². By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in insulin from baseline to two-year follow-up The same secondary outcome will be collected after two years Insulin will only be collected within the type 2 diabetes group. This will be collected by an analysis of a fasting blood sample. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up The same secondary outcome will be collected after two years Diastolic and systolic (mm Hg) blood pressure will be measured twice (interval of one minute) with an automatic OMRON M6 Comfort device after 10 minutes of rest. By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in glucose from baseline to two-year follow-up The same secondary outcome will be collected after two years Glucose will only be collected within the type 2 diabetes group. This will be collected by an analysis of a fasting blood sample. By collecting the same variable on two timepoints, it is possible to determine if this outcome will change or remain stable over time.
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up The same secondary outcome will be collected after two years AGE's are interesting to explore as predictors in developing several comorbidities (e.g. cardiovascular diseases, microvascular complications). Predictors will be measured with an AGE-reader, which is a quick and non-invasive device. By collecting the same variable on three timepoints, it is possible to determine if this outcome will change or remain stable over time.
Trial Locations
- Locations (1)
Ghent University Hospital, Dept. of Endocrinology
🇧🇪Ghent, Belgium