Type-1 DiabetesCanBSDSNCT06287840
Canadian Bone Strength Development Study
An observational study of Type-1 Diabetes, run by University of Saskatchewan at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Type-1 Diabetes
- How many people
- 204 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: primary care clinic, community sample
Who may be able to join
- 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.
Who cannot join
- 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):
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University of Saskatchewan
Saskatoon, Saskatchewan, S7N5B2
Saija Kontulainen, PhD, (306)966-1077, saija.kontulainen@usask.ca
About this study
Official title: Canadian Bone Strength Development in Children With Type 1 Diabetes Study
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:
- 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.
- 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.
- 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.
Read the 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.
- Conditions
- Type-1 Diabetes
- Keywords
- Type-1 Diabetes, Bone, Growth, Children, Physical Activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trabecular Thickness (μm)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Bone Strength (Failure load)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary outcomes (23)
Total, Cortical and Trabecular Bone Area (mm^2)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Total, Cortical and Trabecular Bone Density (mg HA/cm^3)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Cortical Thickness (μm)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Cortical Porosity
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Trabecular Bone Volume Fraction (%)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Trabecular Bone Number (1/mm)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Trabecular Bone Separation (μm)
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Total Body and Hip Bone Mineral Content (g)
Assessed by Dual-energy X-ray absorptiometry (DXA).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Total Body and Hip Areal Bone Mineral Density (g/cm^2)
Assessed by Dual-energy X-ray absorptiometry (DXA).
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Age from Peak Height Velocity (years)
Body mass, height and sitting height will be used to estimate age from peak height velocity.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Pubertal Development
Pubertal development will be determined using Tanner Stages (self-assessed). Participants will be asked to look at drawings of pubic hair and genital or breast development and rate what drawing best reflects their current stage of development. Each set of drawings is associated with a pubertal stage (1-5). Stage 1 indicates pre-pubertal status, stage 2-3 indicates early pubertal status, stage 4 indicates pubertal status and stage 5 indicates post-pubertal status.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Long Jump (m)
The furthest distance an individual can jump while starting from a standing position.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Hand Grip (N)
The highest amount of force one can develop by squeezing their hand. Force is measured using a hand grip dynamometer.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Bone Impacts
Estimate of bone impact activities using a waist-worn accelerometer monitored over 7 days.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Physical Activity (minutes/day)
Estimate of daily moderate-to-vigorous physical activity using a waist-worn accelerometer monitored over 7 days.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Food Frequency Questionnaire
Estimate of daily intakes of calcium, protein and vitamin D. Estimates will be derived using the Food Frequency Questionnaire. Participants will be asked to recall their consumption of various foods over the last 6 months and rate their intake on a scale from Never to consuming the food item 5-6 per week. These ratings are then used to estimate the daily intake of calcum, protein and vitamin D.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Health
For children with type-I diabetes, investigators will record the onset of T1D (years), insulin regimen and various measures of glycemic control (e.g., HbA1c) using open-ended questionnaires and participants' medical records.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Osteocalcin
Biochemical assessment of bone formation.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Procollagen type I N-propeptide (P1NP-N)
Biochemical assessment of bone formation.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
C-terminal telopepide (CTx)
Biochemical assessment of bone resorption.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Sclerostin
Biochemical assessment of bone resorption.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Insulin growth factor-1
Biochemical assessment of hormones.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Alkaline phosphatase
Biochemical assessment of hormones.
Measured: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type-1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Collaborators
- University of Calgary, The Hospital for Sick Children, Children's Hospital of Eastern Ontario
- Responsible party
- Principal investigator, Saija Kontulainen, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06287840
- Sponsor's protocol ID
- 17-301
- Other IDs
- 488294
- Acronym
- CanBSDS
- Status last verified
- Mar 2024
- First submitted
- 6 Feb 2024
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Canadian Bone Strength Development in Children With Type 1 Diabetes Study
- ClinicalTrials.gov ID
- NCT06287840
- Acronym / sponsor ID
- CanBSDS / 17-301
- Conditions
- Type-1 Diabetes
- Keywords
- Type-1 Diabetes, Bone, Growth, Children, Physical Activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Collaborators
- University of Calgary, The Hospital for Sick Children, Children's Hospital of Eastern Ontario
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- primary care clinic, community sample
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Trabecular Thickness (μm)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
Bone Strength (Failure load)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
23 secondary outcomes
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
Hand Grip (N)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Bone Impacts
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Physical Activity (minutes/day)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Food Frequency Questionnaire
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Health
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Osteocalcin
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Procollagen type I N-propeptide (P1NP-N)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
C-terminal telopepide (CTx)
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Sclerostin
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Insulin growth factor-1
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Alkaline phosphatase
Time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type-1 Diabetes, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saija Kontulainen, PhD ((306)966-1077, saija.kontulainen@usask.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trabecular Thickness (μm) (time frame: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.