Skeletal Fragility in Type 1 Diabetes: Glycemic Control and Bone Strength
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Change in bone mineral density by Dual X-ray Absorptometry (DXA)
研究概览
简要总结
The purpose of this research study is to find out how bones are affected in children and adolescents with type 1 diabetes (T1D) as compared to children and adolescents without type 1 diabetes.
详细描述
T1D is primarily associated with decrements in bone strength due to disrupted microarchitecture occurring during peak bone mass accrual, and this disruption arises from hyperglycemia and glycemic variability. Impaired bone development during this period likely predisposes to an increased fracture risk across the lifespan.
The investigators will compare baseline, 12 month and 24 month changes in High-resolution peripheral quantitative computed tomography/micro-finite element analysis (HR-pQCT/μFEA)-based estimates of bone strength and bone turnover by biochemical measurements in 40 T1D children at the onset of peak bone mineral accretion (n=40) versus sex and puberty-matched healthy controls (n=40). The investigators will determine relationships between changes in bone strength (including trabecular and cortical components) and measures of glycemic control and variability by continuous glucose monitoring (CGM).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(T1D and Controls):
- •- Children within 2 years preceding the onset of the pubertal growth spurt
- •Inclusion Criteria (T1D participants):
- •- documentation of β-cell autoimmunity and need for insulin replacement
排除标准
- •Estimated glomerular filtration rate (eGFR)< 60 ml/mim
- •25(OH)D level < 20 ng/ml.
- •Celiac disease
- •Autoimmune thyroid disease
- •Addison's disease
- •History of pathological fractures
- •-- Disorders associated with altered skeletal structure or function
- •Bone active drugs in past year
- •Diabetes of other or unclear etiology
研究组 & 干预措施
Group 1
Those with Type 1 Diabetes.
Group 2
Those without Type 1 Diabetes.
结局指标
主要结局
Change in bone mineral density by Dual X-ray Absorptometry (DXA)
时间窗: Two Years
Measures of DXA
Change in microarchitecture by HR-pQCT
时间窗: Two Years
Measures of HRpQCT
次要结局
未报告次要终点
研究者
Mishaela Rubin
Associate Professor of Medicine
Columbia University