Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06287840
Status:
RECRUITING
Last Update Posted:
2024-03-06
First Post:
2024-02-06
Brief Title:
Canadian Bone Strength Development Study
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Canadian Bone Strength Development in Children With Type 1 Diabetes Study
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CanBSDS
Brief Summary:
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 eg 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
Participants physical growth bone growth muscle strength physical activity and nutrition habits will be assessed and followed up annually for up to 4 years
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 eg 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
Participants physical growth bone growth muscle strength physical activity and nutrition habits will be assessed and followed up annually for up to 4 years
Detailed Description:
The Canadian Bone Strength Development Study is a multi-site project examining differences in bone development between children with and without type-1 diabetes Research for this study will be conducted at the University of Saskatchewan University of Calgary The Hospital for Sick Children SickKids and The Childrens Hospital of Eastern Ontario CHEO 204 children 50 female will be included Participants will make 4 annual visits to the laboratory During each laboratory visit anthropometric measurements eg height and weight bone strength and microarchitecture muscle strength nutrition and physical activity will be assessed Investigators will compare between group differences in bone growth trajectories using multilevel models
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 488294 | OTHER_GRANT | Canadian Institute for Health Research | None |