Canadian Bone Strength Development Study

Type-1 Diabetes Clinical Trial

— CanBSDS  

Official title:

Canadian Bone Strength Development in Children With Type 1 Diabetes Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287840
• Other study ID #: 17-301
• Secondary ID: 488294
• Status: Recruiting
• Start date: April 1, 2024
• Est. completion date: December 31, 2028

Study information

• Verified date: March 2024
• Source: University of Saskatchewan
• Contact: Saija Kontulainen, PhD
• Phone: (306)966-1077
• Email: saija.kontulainen[@]usask.ca
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 204
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type-1 Diabetes

Locations

Country	Name	City	State
Canada	University of Saskatchewan	Saskatoon	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
University of Saskatchewan	Children's Hospital of Eastern Ontario, The Hospital for Sick Children, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trabecular Thickness (µm)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Primary	Bone Strength (Failure load)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Total, Cortical and Trabecular Bone Area (mm^2)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Total, Cortical and Trabecular Bone Density (mg HA/cm^3)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Cortical Thickness (µm)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Cortical Porosity	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Trabecular Bone Volume Fraction (%)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Trabecular Bone Number (1/mm)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Trabecular Bone Separation (µm)	Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Total Body and Hip Bone Mineral Content (g)	Assessed by Dual-energy X-ray absorptiometry (DXA).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Total Body and Hip Areal Bone Mineral Density (g/cm^2)	Assessed by Dual-energy X-ray absorptiometry (DXA).	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Age from Peak Height Velocity (years)	Body mass, height and sitting height will be used to estimate age from peak height velocity.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	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.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Long Jump (m)	The furthest distance an individual can jump while starting from a standing position.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Hand Grip (N)	The highest amount of force one can develop by squeezing their hand. Force is measured using a hand grip dynamometer.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Bone Impacts	Estimate of bone impact activities using a waist-worn accelerometer monitored over 7 days.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Physical Activity (minutes/day)	Estimate of daily moderate-to-vigorous physical activity using a waist-worn accelerometer monitored over 7 days.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	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.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	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.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Osteocalcin	Biochemical assessment of bone formation.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Procollagen type I N-propeptide (P1NP-N)	Biochemical assessment of bone formation.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	C-terminal telopepide (CTx)	Biochemical assessment of bone resorption.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Sclerostin	Biochemical assessment of bone resorption.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Insulin growth factor-1	Biochemical assessment of hormones.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Secondary	Alkaline phosphatase	Biochemical assessment of hormones.	Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up