Actively Recruiting

Age: 10Years - 12Years
All Genders
Healthy Volunteers
NCT06287840

Canadian Bone Strength Development Study

Led by University of Saskatchewan · Updated on 2024-03-06

204

Participants Needed

1

Research Sites

247 weeks

Total Duration

On this page

Sponsors

U

University of Saskatchewan

Lead Sponsor

U

University of Calgary

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Canadian Bone Strength Development Study

Who Can Participate

Age: 10Years - 12Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Females aged 10 to 11 years
  • Males aged 11 to 12 years
  • Diagnosed with type-1 diabetes for at least 6 months (for T1D group)
  • Capacity to give informed consent (patient and parent/guardian); children capable of assent will also provide it
  • Typically developing children meeting the same age and consent criteria (for control group)
Not Eligible

You will not qualify if you...

  • Taking medications or having illnesses affecting bone health, osteoporosis, or physical growth, including renal disease, celiac disease, hypogonadism, hyperthyroidism, or precocious puberty
  • Have undergone adolescent growth spurt at study entry
  • Evidence of pathologic low trauma or vertebral fractures (for control group)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Saskatchewan

Saskatoon, Saskatchewan, Canada, S7N5B2

Actively Recruiting

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Research Team

S

Saija Kontulainen, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Canadian Bone Strength Development Study | DecenTrialz