NCT02248779已完成不适用
Assessing Insulin Sensitivity and Diabetes Risk in Childhood Cancer Survivors Treated With Abdominal Irradiation: A Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- characterize β cell function
研究概览
简要总结
The purpose of this study is to better understand the risk factors and causes of diabetes in people who received radiation to the abdomen as children. The investigators hope this information will allow them to improve how they screen people at risk for diabetes and how they treat patients in the future.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of childhood cancer between 0-21 years of age
- •Prior treatment with abdominal radiation at MSKCC
- •Two or more years from completion of therapy
- •Records of cancer diagnosis and treatment (including radiation records) available
排除标准
- •Known diagnosis of diabetes
- •Previous treatment with any radiation impacting the brain (cranial radiation, craniospinal radiation, total body irradiation)
- •Neurocognitive deficits that impair ability to give informed consent or assent
- •Patients predicted to have difficult intravenous access, who will likely require multiple venipuncture attempts
结局指标
主要结局
characterize β cell function
时间窗: 2 years
we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.
insulin sensitivity
时间窗: 2 years
we will be able to estimate the proportion of patients with abnormalities of insulin sensitivity or β cell function, as assessed by the OGTT, to within ± 0.14.
次要结局
未报告次要终点
研究者
研究点 (1)
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