Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes

NCT ID: NCT03435198

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-01
• Study Completion Date: 2018-08-30

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.

Conditions

Volatile Organic Compounds; Hypoglycemia; Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Collect exhaled breath during low and normal blood sugar

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.

Intervention Type: DIAGNOSTIC_TEST

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

-

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mountain States Health Alliance

UNKNOWN

Sponsor Role: collaborator

East Tennessee State University

OTHER

Sponsor Role: lead

Responsible Party

Evan Los

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evan Los, MD

Role: PRINCIPAL_INVESTIGATOR

East Tennessee State Univerisity

Locations

Mountain States Health Alliance

Johnson City, Tennessee, United States

Countries

United States

Other Identifiers

0817.5f

Identifier Type: -

Identifier Source: org_study_id