Canadian Bone Strength Development in Children With Type 1 Diabetes Study

Status: Recruiting
Location: See location...
Study Type: Observational
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 (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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 12
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Canada
University of Saskatchewan
RECRUITING
Saskatoon
Contact Information
Primary
Saija Kontulainen, PhD
saija.kontulainen@usask.ca
(306)966-1077
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 204
Treatments
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
Control
* Females: 10-11 years old~* Males: 11-12 years old
Related Therapeutic Areas
Sponsors
Collaborators: University of Calgary, Children's Hospital of Eastern Ontario, The Hospital for Sick Children
Leads: University of Saskatchewan

This content was sourced from clinicaltrials.gov