NCT03156179已完成不适用
Assessment of Calcium Metabolism in Adolescent Girls With Type 1 Diabetes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- fractional calcium absorption
研究概览
简要总结
The proposed pilot study will enroll 33 adolescent females with type 1 diabetes for the assessment of whole body calcium metabolism using dual stable calcium isotopes. This is the state of the art technique for assessing calcium metabolism in the body and has been used in both healthy and diseased pediatric populations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 9 Years 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1D of at least three years duration
- •Female sex
- •Age between 9-18 years
- •Parental/guardian consent and participant assent
- •BMI <99th percentile
排除标准
- •History of metabolic bone disease, chronic renal disease, hepatic disease, celiac, or other malabsorptive disease
- •History of any proton-pump inhibitor use within a 6 month period prior to enrollment
- •History of oral or inhaled corticosteroid use for ≥ 5 consecutive days within a 6 month period prior to enrollment
- •Pregnant or lactating females
- •Parents/guardians or participants who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
结局指标
主要结局
fractional calcium absorption
时间窗: 24 hours
Mass spectroscopy was performed using urine to measure the stable calcium isotope. Percent dietary calcium absorption was calculated as the ratio of the cumulative recovery of 44Ca (oral tracer) to the cumulative recovery of 42Ca (IV tracer) in the 24-hour urine sample.
次要结局
- Estimated calcium retention(24 hours)
研究者
David Weber
Assistant Professor
University of Rochester
研究点 (1)
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