24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients

NCT04993482 | Recruiting

• 1 other identifier: BC-10189
• Study Type: observational
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

physical activity; sedentary behavior; sleep

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  The same primary outcome will be collected after two years

Secondary Outcomes (24)

• Change in HbA1c from baseline to two-year follow-up

  baseline

• Change in HbA1c from baseline to two-year follow-up

  The same secondary outcome will be collected after two years

• Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up

  baseline

• Change in cholesterol (total, HDL, LDL) from baseline to two-year follow-up

  The same secondary outcome will be collected after two years

• Change in triglycerides from baseline to two-year follow-up

  Baseline

Other Outcomes (18)

• Explanatory variables: change in demographics from baseline to one and two-year follow-up

  baseline

• Explanatory variables: change in demographics from baseline to one and two-year follow-up

  The same explanatory outcome will be collected after one year

• Explanatory variables: change in demographics from baseline to one and two-year follow-up

  The same explanatory outcome will be collected after two years

Study Arms (2)

type 2 diabetes mellitus group

124 adults with type 2 diabetes mellitus will be included

Other: No intervention

control group

124 control adults will be included

Other: No intervention

Interventions

No intervention OTHER

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.

control group; type 2 diabetes mellitus group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adults aged \>18 years old
• Diagnosed with T2DM by a physician or an HbA1C above 6.5%

You may not qualify if:

• 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
• \- Adults aged \> 18 years old
• 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)

Sponsors & Collaborators

• University Hospital, Ghent: lead
• University Ghent: collaborator

Study Sites (1)

Ghent University Hospital, Dept. of Endocrinology

Ghent, 9000, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 41500620 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

A blood sample will be collected among the type 2 diabetes mellitus group but not among the control group.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavior

Study Officials

• Bruno Lapauw, Professor

  Ghent University Hospital - endocrinologist

  PRINCIPAL INVESTIGATOR

• Marieke De Craemer, Professor

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iris Willems, PhD student

CONTACT

093323638; willems.iris@ugent.be

Marieke De Craemer, Professor

CONTACT

09 332 52 08; Marieke.Decraemer@ugent.be

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: August 6, 2021
• Study Start: August 29, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

BE (1)