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Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT03435198
Recruitment Status : Active, not recruiting
First Posted : February 15, 2018
Last Update Posted : June 27, 2018
Sponsor:
Collaborator:
Mountain States Health Alliance
Information provided by (Responsible Party):
Evan Los, East Tennessee State University

Brief Summary:
The investigators are investigating the "biochemical fingerprint" of hypoglycemia (low blood sugar) in the breath of people with type 1 diabetes.

Condition or disease Intervention/treatment Phase
Volatile Organic Compounds Hypoglycemia Type 1 Diabetes Mellitus Diagnostic Test: Collect exhaled breath during low and normal blood sugar Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine



Intervention Details:
  • Diagnostic Test: 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.


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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 ]
    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))

  2. Identify differences in patterns of exhaled VOCs in people who have hypoglycemia unawareness [ Time Frame: up to 1 month ]
    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



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Ages Eligible for Study:   5 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435198


Locations
United States, Tennessee
Mountain States Health Alliance
Johnson City, Tennessee, United States, 37604
Sponsors and Collaborators
East Tennessee State University
Mountain States Health Alliance
Investigators
Principal Investigator: Evan Los, MD East Tennessee State Univerisity

Responsible Party: Evan Los, Assistant Professor, East Tennessee State University
ClinicalTrials.gov Identifier: NCT03435198     History of Changes
Other Study ID Numbers: 0817.5f
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases