Metabolites in Blood and Breath in Metabolic Conditions
Measurement of Metabolites in the Breath and Blood in Patients With Altered Metabolism and Healthy Individuals
In patients with inborn errors of metabolism (IEM) and in those requiring a ketogenic diet for the treatment of medical conditions, relevant biochemical analytes are routinely and regularly measured in venous or capillary blood samples. Repeated venipuncture for blood collection is invasive, burdensome, and resource-intensive. As an alternative, capillary blood sampling can provide some relief for the measurement of a limited number of metabolites. Nevertheless, the frequent finger pricks required to obtain capillary blood samples can still be uncomfortable for patients. Therefore, patients could benefit if non-invasive breath measurements were to replace the currently invasive biochemical monitoring methods in the future.
In this study, the usability of metabolite measurements across matrices (venous blood, capillary blood, breath captured by a handheld sensor and breath in a collection bag) in IEM patients, individuals prescribed special health-related diets, and healthy volunteers will be investigated. The usability of a handheld breath sensor for remote monitoring of patients will also be tested. Lastly, exploratory investigations will be performed to identify new disease biomarkers in breath.
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名：Johannes Häberle
- 电话号码：+41 44 249 59 88
- 邮箱：Johannes.Haeberle@kispi.uzh.ch
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- Patients aged 4-20 years old with refractory epilepsy on a ketogenic diet, or
- Patients aged 4 years old and above with a confirmed diagnosis of urea cycle disorders, organic acidurias, amino acidopathies and fatty acid oxidation defects, or
- healthy adults and
- informed consent
Exclusion Criteria:
- Physical findings at screening that would compromise safety of the participant or quality of study data. Examples include presentation of fever, pulmonary complications, presence of disease comorbidities that might interfere with study result and inability to comply with study procedures.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Patients or healthy adult volunteers
|
no intervention
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Concentration (μmol/L) of metabolites of clinical interest in venous blood, capillary blood and breath of participants.
大体时间：Baseline
|
|
Baseline
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Correlation of metabolite concentrations in different matrices
大体时间：Baseline
|
|
Baseline
|
|
Participant self-report questionnaire on a 4-point Likert scale on the burden of each sampling method
大体时间：Baseline
|
Likert scale: 1, Strongly Agree.
2, Agree.
3, Disagree.
4, Strongly Disagree.
The lower the score, the lower the burden of sampling method.
|
Baseline
|
|
Participant self-report questionnaire on a 4-point Likert scale on the usability of the handheld breath sensor for remote measurements of metabolites
大体时间：Baseline
|
Likert scale: 1, Strongly Agree.
2, Agree.
3, Disagree.
4, Strongly Disagree.
The lower the score, the higher the acceptance of using the handheld breath sensor.
|
Baseline
|
|
Untargeted SESI-based mass spectrometry analysis of exhaled breath captured in a bag
大体时间：Baseline
|
abundance (parts per million) of all detectable and identifiable metabolites in exhaled breath
|
Baseline
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.