Clinical trial NCT03435198: Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Official title: Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Volatile Organic Compounds
Hypoglycemia
Type 1 Diabetes Mellitus
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
Collaborators: name: Mountain States Health Alliance
First posted: 2018-02-15
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with type 1 diabetes between age 5-80.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

-

Primary outcomes:
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.
timeFrame: 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:
measure: 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.
timeFrame: up to 1 month
measure: Identify differences in patterns of exhaled VOCs in people who have hypoglycemia unawareness
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Johnson City
country: United States
facility: Mountain States Health Alliance
state: Tennessee
Study officials:
affiliation: East Tennessee State Univerisity
name: Evan Los, MD
role: PRINCIPAL_INVESTIGATOR
References: