Clinical trial NCT06287840: Canadian Bone Strength Development Study
Official title: Canadian Bone Strength Development in Children With Type 1 Diabetes Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Type-1 Diabetes
Keywords: Type-1 Diabetes
Bone
Growth
Children
Physical Activity
Lead sponsor: University of Saskatchewan
Sponsor class: OTHER
Collaborators: name: University of Calgary
name: The Hospital for Sick Children
name: Children's Hospital of Eastern Ontario
First posted: 2024-03-01
Enrollment: 204
Sex: ALL
Minimum age (years): 10
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic, community sample

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 (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.

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.

Primary outcomes:
measure: Trabecular Thickness (μm)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Bone Strength (Failure load)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary outcomes:
measure: Total, Cortical and Trabecular Bone Area (mm^2)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Total, Cortical and Trabecular Bone Density (mg HA/cm^3)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Cortical Thickness (μm)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Cortical Porosity
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Trabecular Bone Volume Fraction (%)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Trabecular Bone Number (1/mm)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Trabecular Bone Separation (μm)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Total Body and Hip Bone Mineral Content (g)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Total Body and Hip Areal Bone Mineral Density (g/cm^2)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Age from Peak Height Velocity (years)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Pubertal Development
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Long Jump (m)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Hand Grip (N)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Bone Impacts
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Physical Activity (minutes/day)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Food Frequency Questionnaire
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Health
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Osteocalcin
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Procollagen type I N-propeptide (P1NP-N)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: C-terminal telopepide (CTx)
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Sclerostin
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Insulin growth factor-1
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
measure: Alkaline phosphatase
timeFrame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Other outcomes:
Locations:
city: Saskatoon
country: Canada
facility: University of Saskatchewan
state: Saskatchewan
Study officials:
References: