Bone Mineral Accrual and Microarchitecture in Youth With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 242
- 试验地点
- 1
- 主要终点
- Rate of bone mineral accrual
研究概览
简要总结
This is an observational study of children and young adults ages 6-20 years with type 1 diabetes and age- and race-matched controls. The investigators will be examining blood and urine hormone levels as well as measures of bone density including DXA and high-resolution peripheral quantitiative computed tomography. The investigators will also be collecting data regarding physical activity via use of wearable accelerometers. The investigators hypothesize that youth with type 1 diabetes will have slower bone accrual and impaired bone microarchitectural integrity compared with non-diabetic controls, and that bones of individuals with type 1 diabetes will not respond as well to physical activity. The investigators hypothesize that poor bone accrual will be associated with sub-optimal glucose control as well as lower levels of insulin-like growth factor 1.
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
- 6 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 6-20 years
- •Out of honeymoon period (cohort with diabetes)
排除标准
- •BMI<5th percentile for age
- •BMI>95th percentile for age
- •Celiac disease
- •Hyperthyroidism, uncontrolled hypothyroidism
- •History of significant hepatic disease, renal disease, oncologic disease, cardiovascular disease, psychiatric disease
- •Anemia (Hgb <11)
- •Taking medications other than insulin known to affect bone health (including hormonal contraception, glucocorticoids, growth hormone)
结局指标
主要结局
Rate of bone mineral accrual
时间窗: 0, 12, 24 months
Bone mineral mass and density will be measured by dual-energy x-ray absorptiometry (DXA) at baseline and 12 months. Percent change over time will be calculated and then compared in subjects with type 1 diabetes and matched control subjects.
次要结局
- Change bone microarchitectural parameters in patients with diabetes vs. controls(0 and 24 months)
- Cross-sectional comparison of bone microarchitectural parameters in patients with diabetes vs. controls(Baseline)
- Rate of bone mineral accrual(0 and 24 months)
研究者
Deborah Mitchell, MD
Assistant Professor in Pediatrics
Massachusetts General Hospital