Comparison Between Breath Acetone and Blood Beta-Hydroxybutyrate
Relationship Among Breath Acetone, Blood Beta-Hydroxybutyrate, and Blood Glucose
1 other identifier
observational
61
1 country
1
Brief Summary
Subjects will provide blood and breath samples to evaluate the relationship between breath acetone and two blood-bound species: beta-hydroxybutyrate and glucose. Subjects will be asked to provide breath and blood samples at a baseline visit and second optional visit. The two visits will be spaced approximately 3 hours apart.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2017
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 12, 2017
CompletedFirst Submitted
Initial submission to the registry
September 22, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 16, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2018
CompletedAugust 29, 2018
August 1, 2018
5 months
September 22, 2017
August 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Breath acetone concentration (ppm) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.
Both individual and average group measurements will be compared
Through study completion, 4 months
Secondary Outcomes (2)
Breath acetone concentration (ppm) will be compared against blood glucose concentration (mg/dL). The following methods may be used: summary statistics, plotting, and linear regression.
Through study completion, 4 months
Blood glucose concentration (mg/dL) will be compared against blood BOHB concentration (mM). The following methods may be used: summary statistics, plotting, and linear regression.
Through study completion, 4 months
Study Arms (1)
Healthy adults
Healthy adults who are able to provide duplicate breath samples and pin-drop blood samples
Interventions
Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone
Eligibility Criteria
Healthy individuals
You may qualify if:
- \. Subject must complete the consent process
You may not qualify if:
- Subjects with severe lung disease which would prevent them from providing a breath sample through a large bore tube (e.g., large drinking straw)
- Subjects with diabetes (Type 1 or Type 2)
- Subjects who are routinely exposed to paints, paint thinners, gasoline, varnishes, glues, dry cleaning solvents, or industrial cleaning products
- Daily smoker of cigarettes, e-cigarettes, or marijuana
- Abstain from alcohol over the prior 24 hours
- Refrain from consumption of large amounts of garlic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medamonitorlead
Study Sites (1)
Medamonitor, LLC
Seattle, Washington, 98119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph C Anderson, PhD
Medamonitor
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2017
First Posted
October 3, 2017
Study Start
September 12, 2017
Primary Completion
February 16, 2018
Study Completion
February 28, 2018
Last Updated
August 29, 2018
Record last verified: 2018-08