Canadian Bone Strength Development in Children With Type 1 Diabetes Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- Trabecular Thickness (μm)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Trabecular Thickness (μm)
时间窗: 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)
时间窗: Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up
Assessed by high-resolution peripheral quantitative computed tomography (HRpQCT).
次要结局
- Cortical Thickness (μm)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Trabecular Bone Volume Fraction (%)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Total, Cortical and Trabecular Bone Density (mg HA/cm^3)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Food Frequency Questionnaire(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Health(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Procollagen type I N-propeptide (P1NP-N)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Sclerostin(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Alkaline phosphatase(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Total Body and Hip Areal Bone Mineral Density (g/cm^2)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Pubertal Development(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Long Jump (m)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- C-terminal telopepide (CTx)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Trabecular Bone Number (1/mm)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Age from Peak Height Velocity (years)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Hand Grip (N)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Physical Activity (minutes/day)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Insulin growth factor-1(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Total, Cortical and Trabecular Bone Area (mm^2)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Cortical Porosity(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Trabecular Bone Separation (μm)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Bone Impacts(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Total Body and Hip Bone Mineral Content (g)(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
- Osteocalcin(Baseline, year 1 follow-up, year 2 follow-up, year 3 follow-up)
研究者
Saija Kontulainen
Professor, Associate Dean Research and Graduate Studies, Graduate Chair
University of Saskatchewan