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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Johannes Häberle
- 電話番号：+41 44 249 59 88
- メール：Johannes.Haeberle@kispi.uzh.ch
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients or healthy adult volunteers
|
no intervention
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Concentration (μmol/L) of metabolites of clinical interest in venous blood, capillary blood and breath of participants.
時間枠：Baseline
|
|
Baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Correlation of metabolite concentrations in different matrices
時間枠：Baseline
|
|
Baseline
|
|
Participant self-report questionnaire on a 4-point Likert scale on the burden of each sampling method
時間枠：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
時間枠：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
時間枠：Baseline
|
abundance (parts per million) of all detectable and identifiable metabolites in exhaled breath
|
Baseline
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。