Diabetes Mellitus, Type 2NCT04993482
24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
An observational study of Diabetes Mellitus, Type 2, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- How many people
- 248 participants
- Where
- 1 siteBelgium
- Study dates
- 29 Aug 2021to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Adults aged >18 years old
- Diagnosed with T2DM by a physician or an HbA1C above 6.5%
- Adults aged > 18 years old
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital, Dept. of Endocrinology
Ghent, 9000
Bruno Lapauw, MD, PhD
About this study
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- No intervention
- Keywords
- physical activity, sedentary behavior, sleep
- Medical subject headings
- Diabetes Mellitus, Type 2, Motor Activity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
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 group | Role | What they receive |
|---|---|---|
| type 2 diabetes mellitus group | 124 adults with type 2 diabetes mellitus will be included Receives: Other: No intervention | |
| control group | 124 control adults will be included Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in 24-hour movement composition from baseline over one year and two-year follow-up
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.
Measured: Baseline
Change in 24-hour movement composition from baseline over one year and two-year follow-up
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.
Measured: The same primary outcome will be collected after one year
Change in 24-hour movement composition from baseline over one year and two-year follow-up
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.
Measured: The same primary outcome will be collected after two years
Secondary outcomes (24)
Change in HbA1c from baseline to two-year follow-up
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.
Measured: baseline
Change in HbA1c from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
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.
Measured: baseline
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in triglycerides from baseline to two-year follow-up
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.
Measured: Baseline
Change in triglycerides from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in insulin from baseline to two-year follow-up
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.
Measured: Baseline
Change in insulin from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in glucose from baseline to two-year follow-up
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.
Measured: Baseline
Change in glucose from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
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.
Measured: Baseline
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
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.
Measured: baseline
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after one year
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in waist circumference from baseline to one and two-year follow-up
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.
Measured: Baseline
Change in waist circumference from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after one year
Change in waist circumference from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
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.
Measured: baseline
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after one year
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
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.
Measured: baseline
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after one year
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
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.
Measured: The same secondary outcome will be collected after two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2021
- Study start29 Aug 2021
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
- Investigators
- Bruno Lapauw, Professor, Principal investigator, Ghent University Hospital - endocrinologistMarieke De Craemer, Professor, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04993482
- Sponsor's protocol ID
- BC-10189
- Status last verified
- Dec 2023
- First submitted
- 9 Jul 2021
- Last updated
- 8 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bogaert L, De Craemer M, Dirinck E, Calders P, Lapauw B, Willems I. 24-hour movement behaviours and cardiometabolic health in adults with type 2 diabetes: a comparative cross-sectional and longitudinal analysis. BMJ Open. 2026 Jan 6;16(1):e098988. doi: 10.1136/bmjopen-2025-098988.
PubMed 41500620
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients
- ClinicalTrials.gov ID
- NCT04993482
- Acronym / sponsor ID
- BC-10189
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- physical activity, sedentary behavior, sleep
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 6 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetes mellitus group | – | Other: No intervention124 adults with type 2 diabetes mellitus will be included |
| control group | – | Other: No intervention124 control adults will be included |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Adults aged >18 years old
- Diagnosed with T2DM by a physician or an HbA1C above 6.5%
- Adults aged > 18 years old
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThis 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. | Other | control group, type 2 diabetes mellitus group |
Primary outcome
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time frame: Baseline
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.
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time frame: The same primary outcome will be collected after one year
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.
Change in 24-hour movement composition from baseline over one year and two-year follow-up
Time frame: 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.
24 secondary outcomes
Change in HbA1c from baseline to two-year follow-up
Time frame: baseline
Change in HbA1c from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
Time frame: baseline
Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in triglycerides from baseline to two-year follow-up
Time frame: Baseline
Change in triglycerides from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in insulin from baseline to two-year follow-up
Time frame: Baseline
Change in insulin from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in glucose from baseline to two-year follow-up
Time frame: Baseline
Change in glucose from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
Time frame: Baseline
Change in Homeostatic Model Assessment (HOMA) from baseline to two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time frame: baseline
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after one year
Change in Body Mass Index (BMI) from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in waist circumference from baseline to one and two-year follow-up
Time frame: Baseline
Change in waist circumference from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after one year
Change in waist circumference from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time frame: baseline
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after one year
Change in systolic and diastolic blood pressure from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time frame: baseline
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after one year
Change in Advanced Glycation Endproducts from baseline to one and two-year follow-up
Time frame: The same secondary outcome will be collected after two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
- Derived from this study: PubMed 41500620Bogaert L, De Craemer M, Dirinck E, Calders P, Lapauw B, Willems I. 24-hour movement behaviours and cardiometabolic health in adults with type 2 diabetes: a comparative cross-sectional and longitudinal analysis. BMJ Open. 2026 Jan 6;16(1):e098988. doi: 10.1136/bmjopen-2025-098988.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Lapauw, Professor principal investigator
Ghent University Hospital - endocrinologist
Marieke De Craemer, Professor principal investigator
University Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iris Willems, PhD student (093323638, willems.iris@ugent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 24-hour movement composition from baseline over one year and two-year follow-up (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04993482, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.