Volatile Organic CompoundsNCT03435198
Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
An observational study of Volatile Organic Compounds and Hypoglycemia, run by East Tennessee State University at 1 site in United States.
Trial summary
The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 5 to 80 years
- Conditions the study is for
- Volatile Organic Compounds, Hypoglycemia, Type 1 Diabetes Mellitus
- What is being tested?
- Collect exhaled breath during low and normal blood sugar
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 30 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: People with type 1 diabetes between age 5-80.
Who may be able to join
- Have a diagnosis of type 1 diabetes
- No current or planned tobacco/nicotine use including vaping during the study
- Are not pregnant or planning to become pregnant during the study timeframe
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Mountain States Health Alliance
Johnson City, Tennessee, 37604
About this study
The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes.
Read the detailed description
The investigators aim through the use of proton-transfer-reaction mass spectrometry to perform comprehensive breath analysis to identify compounds of interest associated with glucose fluctuations. More than 500 different volatile organic compounds can be detected in human breath. Compounds such as ethane, pentane and isoprene (hydrocarbons), as well as acetone, acetaldehyde, methanol, ethanol, 2-propanol (oxygen-containing compounds), are most likely to be relevant and measurable in our study population. Hydrocarbons are stable end-products of lipid peroxidation and show only low solubility in blood and therefor are excreted into breath within minutes of their formation in tissues. There is evidence for increased hydrocarbon production in states of oxidative stress. Oxygen-containing compounds such as acetone/acetaldehyde (ketones) are also clinically relevant in the measurement of insulin deficient states of catabolism in patients with diabetes. A previous study of exhaled isoprene was found to be elevated during hypoglycemia. This study aims to expand on this to characterize the full range of changes in concentrations of volatile organic compounds in human breath during glucose fluctuations.
Characterizing this "biochemical fingerprint" of hypoglycemia may provide clues about what so-called diabetes alert dogs are detecting as well as improve our understanding of hypoglycemia, the physiology behind hypoglycemia unawareness, and potentially identify a novel non-invasive measure of blood glucose.
- Being tested
- Collect exhaled breath during low and normal blood sugar
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collect exhaled breath during low and normal blood sugarDiagnostic test
Collect exhaled breath during low and normal blood sugar to determine if there are any differences between the two in people with type 1 diabetes.
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute and relative change in concentration of measured volatile organic compounds in human breath in subjects with type 1 diabetes during hypoglycemia compared to euglycemia measured by proton-transfer-reaction time-of-flight mass spectrometry.
Detectable difference in volatile organic compounds (anticipate up to 120-150 different ion signals to be assessed) in human breath during low blood sugar (<70 mg/dL) compared to normal blood sugar (70-180). As this is a 'hypothesis generating' pilot study, the investigators are observing what compounds are present and in what concentrations -- this is the reason for nonspecific outcome measures
Measured: Until three low blood sugar events have occured with breath samples collected during low blood sugar and upon recovery to normal blood sugar; expected 1-2 weeks but allowed up to 1 month to complete sample collection
Secondary outcomes (2)
Characterize relationship of concentration of all measurable VOCs (anticipate 120-150 ion signals) by proton-transfer-reaction time-of-flight mass spectrometry across the spectrum of glycemia.
Statistically-significant (P<0.05) differences in concentration of volatile organic compounds in human breath in subjects with type 1 diabetes across the spectrum of glycemia (very low <54 mg/dL), low (55-69), in target (70-180), high (181-250), very high(>250))
Measured: up to 1 month
Identify differences in patterns of exhaled VOCs in people who have hypoglycemia unawareness
Statistically significant (P<0.05) differences in patterns of exhaled VOCs between subjects with and without hypoglycemia unawareness identified by standardized hypoglycemia unawareness survey tools
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start1 Mar 2018
- Primary completion30 Aug 2018
- Study completion30 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volatile Organic CompoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Collaborators
- Mountain States Health Alliance
- Responsible party
- Principal investigator, Evan Los, East Tennessee State University
- Investigators
- Evan Los, MD, Principal investigator, East Tennessee State Univerisity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03435198
- Sponsor's protocol ID
- 0817.5f
- Status last verified
- Feb 2019
- First submitted
- 30 Jan 2018
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03435198
- Acronym / sponsor ID
- 0817.5f
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Collaborators
- Mountain States Health Alliance
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Aug 2018 (actual)
- Study completion
- 30 Aug 2018 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes.
Detailed description
The investigators aim through the use of proton-transfer-reaction mass spectrometry to perform comprehensive breath analysis to identify compounds of interest associated with glucose fluctuations. More than 500 different volatile organic compounds can be detected in human breath. Compounds such as ethane, pentane and isoprene (hydrocarbons), as well as acetone, acetaldehyde, methanol, ethanol, 2-propanol (oxygen-containing compounds), are most likely to be relevant and measurable in our study population. Hydrocarbons are stable end-products of lipid peroxidation and show only low solubility in blood and therefor are excreted into breath within minutes of their formation in tissues. There is evidence for increased hydrocarbon production in states of oxidative stress. Oxygen-containing compounds such as acetone/acetaldehyde (ketones) are also clinically relevant in the measurement of insulin deficient states of catabolism in patients with diabetes. A previous study of exhaled isoprene was found to be elevated during hypoglycemia. This study aims to expand on this to characterize the full range of changes in concentrations of volatile organic compounds in human breath during glucose fluctuations.
Characterizing this "biochemical fingerprint" of hypoglycemia may provide clues about what so-called diabetes alert dogs are detecting as well as improve our understanding of hypoglycemia, the physiology behind hypoglycemia unawareness, and potentially identify a novel non-invasive measure of blood glucose.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People with type 1 diabetes between age 5-80.
Key inclusion criteria (3 listed)
- Have a diagnosis of type 1 diabetes
- No current or planned tobacco/nicotine use including vaping during the study
- Are not pregnant or planning to become pregnant during the study timeframe
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collect exhaled breath during low and normal blood sugarCollect exhaled breath during low and normal blood sugar to determine if there are any differences between the two in people with type 1 diabetes. | Diagnostic test | – |
Primary outcome
Absolute and relative change in concentration of measured volatile organic compounds in human breath in subjects with type 1 diabetes during hypoglycemia compared to euglycemia measured by proton-transfer-reaction time-of-flight mass spectrometry.
Time frame: Until three low blood sugar events have occured with breath samples collected during low blood sugar and upon recovery to normal blood sugar; expected 1-2 weeks but allowed up to 1 month to complete sample collection
Detectable difference in volatile organic compounds (anticipate up to 120-150 different ion signals to be assessed) in human breath during low blood sugar (<70 mg/dL) compared to normal blood sugar (70-180). As this is a 'hypothesis generating' pilot study, the investigators are observing what compounds are present and in what concentrations -- this is the reason for nonspecific outcome measures
2 secondary outcomes
Characterize relationship of concentration of all measurable VOCs (anticipate 120-150 ion signals) by proton-transfer-reaction time-of-flight mass spectrometry across the spectrum of glycemia.
Time frame: up to 1 month
Identify differences in patterns of exhaled VOCs in people who have hypoglycemia unawareness
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evan Los, MD principal investigator
East Tennessee State Univerisity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Volatile Organic Compounds and Hypoglycemia, run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute and relative change in concentration of measured volatile organic compounds in human breath in subjects with type 1 diabetes during hypoglycemia compared to euglycemia measured by proton-transfer-reaction time-of-flight mass spectrometry. (time frame: Until three low blood sugar events have occured with breath samples collected during low blood sugar and upon recovery to normal blood sugar; expected 1-2 weeks but allowed up to 1 month to complete sample collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.