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Recruiting NCT04993482

24-hour Movement Behaviors Among Type 2 Diabetes Mellitus Patients

— Observational Diabetes Mellitus, Type 2

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No intervention.
Who it may be relevant to
Registry conditions: Diabetes Mellitus, Type 2. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

Interventions

  • Other No intervention
    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.

Primary outcome measures

  • Change in 24-hour movement composition from baseline over one year and two-year follow-up [Time frame: Baseline]
  • 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]
  • 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]
Secondary outcome measures (12)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Belgium · 1 center
  • Ghent University Hospital, Dept. of Endocrinology — Ghent

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. PMID 41500620

Identifiers

NCT: NCT04993482 · BC-10189

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗