NCT02216201撤回不适用
Clinical Utility of SUDOSCAN in the Pediatric Population
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
研究概览
简要总结
The main purpose of this study is to evaluate whether SUDOSCAN is a valid, accurate clinical device for the the determination of sweat gland function in the pediatric population.
Primary Objective: To measure sweat gland function in a pediatric population
Secondary Objective: To determine thresholds on the SUDOSCAN scale for abnormal sweat gland function in the pediatric population
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 17 Years(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females ages 8 to 17 years
- •Able to give assent as well as parental consent
排除标准
- •History of type 1 or type 2 diabetes
- •Chronic autoimmune condition
- •Taking chronic immunosuppressive or anti-inflammatory medications
- •Unable to apply palms of the hands and soles of the feet on the sensor plates during a 3 minute Sudoscan test
- •Presence of hepatitis B or C
- •Presence of HIV
- •Presence of known neurological disorder
- •Pregnancy and/or breastfeeding
- •Any open wound on the soles of the feet or palms of the hands
- •Participation in an ongoing clinical investigational drug trial
- •Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study
结局指标
主要结局
Identification of participants with abnormal SUDOSCAN electrochemical skin conductance scores
时间窗: Baseline
* Sweat gland function will be assessed within each age group * Correlation with parameters associated with pre-diabetes and diabetes
次要结局
未报告次要终点
研究者
研究点 (1)
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