Canadian Bone Strength Development Study

Official title

Canadian Bone Strength Development in Children With Type 1 Diabetes Study

Overview

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.

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 Children's 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 (e.g., 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.

Primary outcome measures

• Trabecular Thickness (μm) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Bone Strength (Failure load) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]

Secondary outcome measures (12)

• Total, Cortical and Trabecular Bone Area (mm^2) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Total, Cortical and Trabecular Bone Density (mg HA/cm^3) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Cortical Thickness (μm) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Cortical Porosity [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Trabecular Bone Volume Fraction (%) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Trabecular Bone Number (1/mm) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Trabecular Bone Separation (μm) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Total Body and Hip Bone Mineral Content (g) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Total Body and Hip Areal Bone Mineral Density (g/cm^2) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Age from Peak Height Velocity (years) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Pubertal Development [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]
• Long Jump (m) [Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up]

Eligibility criteria

Children with Type-I Diabetes:

Inclusion criteria

• 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.

Exclusion criteria

• 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 gone through adolescent growth spurt at study entry.

Control Group (Typically Developing Children):

Inclusion criteria

• 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 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Other

Study locations

Canada · 1 center

• University of Saskatchewan — Saskatoon

Identifiers

NCT: NCT06287840 · 17-301 · 488294

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗