Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
204 participants
OBSERVATIONAL
2024-04-01
2028-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
1. Assess how and when sex-specific bone developmental trajectories in the leg and arm will differ between children with T1D and control cohorts relative to the critical period of rapid skeletal growth in puberty. It is hypothesized that children with T1D will have inferior bone development, particularly lower gains in bone strength.
2. Assess why bone trajectories differ between T1D and control cohorts by identifying the role of body composition, site-specific muscle force and physical activity on differences in bone properties in female and male children with and without T1D. It is hypothesized that children with T1D will have lower gains in lean mass, muscle force, number of daily bone impacts and minutes of moderate-vigorous physical activity and will be associated with inferior gains in bone development.
3. Assess why T1D may impair sex-specific bone development by exploring the role of disease-related factors (e.g., duration, glucose control, hormones and markers of bone turnover) and fracture history on bone trajectories of children with T1D. It is hypothesized that longer exposure to T1D, poorer glucose control, alterations in hormones, lower bone formation markers and higher history of fracture will be negatively associated with bone trajectories of children with T1D.
Participant's physical growth, bone growth, muscle strength, physical activity and nutrition habits will be assessed and followed up annually for up to 4 years.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone Health in Youth With Type 1 Diabetes
NCT02140424
Type 1 Diabetes Mellitus Bone Mineral Density in Childhood and Adolescence
NCT01605149
Bone Health and Microbiome in Persons With Type 1 Diabetes
NCT04784975
Bone Health in Type 1 Diabetes
NCT00651196
Impact of Glycemic Control on Skeletal Outcomes in Adults With Type 1 Diabetes
NCT06351176
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Children with Type-1 Diabetes
* Females: 10-11 years old
* Males: 11-12 years old
* Diagnosed with type-1 diabetes for at least 6 months
No interventions assigned to this group
Control
* Females: 10-11 years old
* Males: 11-12 years old
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Males: 11 - 12 years old.
* Diagnosed with type-1 diabetes for at least 6 months.
* Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent.
* Females: 10-11 years old.
* Males: 11 - 12 years old.
* Capacity to give informed consent (patient and parent/guardian). Children with the capacity to give assent will do so in addition to parental consent.
Exclusion Criteria
* Have gone through adolescent growth spurt at study entry.
Control Group (Typically Developing Children):
* Have an illness or are taking medications influencing bone health or physical growth.
* Evidence of pathologic low trauma or vertebral fracture(s).
* Have gone through adolescent growth spurt at study entry.
10 Years
12 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Calgary
OTHER
The Hospital for Sick Children
OTHER
Children's Hospital of Eastern Ontario
OTHER
University of Saskatchewan
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Saija Kontulainen
Professor, Associate Dean Research and Graduate Studies, Graduate Chair
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
488294
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
17-301
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.