Pilot Study - Type 1 Diabetes and Bone Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- histomorphometry measurements
研究概览
简要总结
An increased skeletal fracture risk in diabetes has only recently been recognized. This human study is designed to elucidate the effect of Type 1 diabetes on bone remodeling and on structure.
详细描述
An increased skeletal fracture risk in diabetes has only recently been recognized. Human studies of patients with diabetes using bone mineral density and bone markers have noted low bone mass and mixed results on remodeling activity. Mouse models of diabetes have suggested that low bone turnover is the underlying problem. Low bone turnover could lead to an accumulation of microdamage that is not repaired causing compromised bone strength. Low bone turnover has not yet been confirmed in humans. This human study is designed to elucidate the effect of Type 1 diabetes on 1) bone remodeling, including histomorphometric and biochemical measures of bone formation and resorption, and 2) on structure, including micro architectural arrangement of trabeculae and bone mineral density.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 19 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 19 yrs or < 50 yrs.
- •The diabetic subjects must have a diagnosis of Type 1 diabetes clinically defined as diabetes onset before age 50, acute presentation or diabetic ketoacidosis, with normal BMI. If history is equivocal, GAD antibodies > 1.45 U/mL will be used to define diagnosis.
- •Diabetic subjects must be on insulin treatment.
- •All subjects must have BMI between 18-30
排除标准
- •On any medications that are known to interfere with bone metabolism including loop diuretics, steroids, anticonvulsants, bisphosphonates, metformin, glitazones
- •Have normal or only mildly impaired kidney function defined as a calculated GFR greater than 60 mL/min/1.73m2
- •History of cancer other than skin cancer
- •Unstable angina, myocardial infarction, uncontrolled hypertension, malabsorption, active rheumatoid or collagen disease.
结局指标
主要结局
histomorphometry measurements
时间窗: at 2nd visit
次要结局
- nanoindentation measurements(at 2nd visit)
- Bone mineral density(at 1st visit)
- peripheral QCT measurements(at 1st visit)
- micro CT measurements(at 2nd visit)
研究者
Laura Armas
Assistant Professor
Creighton University