NCT06287840Recruiting
Canadian Bone Strength Development Study
Canadian Bone Strength Development in Children With Type 1 Diabetes Study
Source: ClinicalTrials.gov · Last updated 6 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this project is to learn about differences in bone development between children with and without type-1 diabetes (T1D). The main questions this study aims to answer are: 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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 204 (estimated)
- First submitted
- 6 Feb 2024
- Start date
- 1 Apr 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Saskatchewan
- Diseases
- Type 1 diabetes
- NCT number
- NCT06287840
What you commit to
- Study type: Observational
- Planned participants: 204
- From 1 Apr 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Consuming any medications or have additional illnesses associated with bone health, osteoporosis (including renal disease, celiac disease, hypogonadism, hyperthyroidism) or altered physical growth (precocious puberty).
- Have an illness or are taking medications influencing bone health or physical growth.
Other
- Have gone through adolescent growth spurt at study entry.
- Control Group (Typically Developing Children):
- Evidence of pathologic low trauma or vertebral fracture(s).
- Have gone through adolescent growth spurt at study entry.
Who the study is looking for
- Females: 10-11 years old.
- 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.
Criteria the registry did not label
- Children with Type-I Diabetes:
Age in the registry: 10 years to 12 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Saskatchewan Coordinator of this site? Confirm its status | Saskatoon | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.