Recruiting

Bone Strength

Sponsor:

University of Saskatchewan

Code:

NCT06287840

Conditions

Type-1 Diabetes

Eligibility Criteria

Sex: All

Age: 10 - 12

Healthy Volunteers: Accepted

Study Details

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.

Conditions

Type-1 Diabetes

Study ID

NCT06287840

Start date

Apr 1, 2024

Status verified date

Mar, 2024

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 10 - 12

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

204 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Saija Kontulainen, PhD

(306)966-1077saija.kontulainen@usask.ca

Locations

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada, S7N5B2

Contacts

Saija Kontulainen, PhD

(306)966-1077saija.kontulainen@usask.ca

More Information

Sponsor

University of Saskatchewan

Last update posted

Mar 6, 2024

Last verified

Mar, 2024

Keywords

  • Type-1 Diabetes
  • Bone
  • Growth
  • Children
  • Physical Activity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Saskatchewan on 2024-03-06.