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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 : Completed
First Posted : February 15, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Mountain States Health Alliance
Information provided by (Responsible Party):
Evan Los, East Tennessee State University

Tracking Information
First Submitted Date January 30, 2018
First Posted Date February 15, 2018
Last Update Posted Date February 15, 2019
Actual Study Start Date March 1, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 14, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03435198 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 14, 2018)
  • 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))
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
Official Title Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
human breath samples collected in sealed bags and shipped to receiving/processing lab. Once processed, samples are destroyed.
Sampling Method Non-Probability Sample
Study Population People with type 1 diabetes between age 5-80.
Condition
  • Volatile Organic Compounds
  • Hypoglycemia
  • Type 1 Diabetes Mellitus
Intervention 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.
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 14, 2018)
10
Original Estimated Enrollment Same as current
Actual Study Completion Date August 30, 2018
Actual Primary Completion Date August 30, 2018   (Final data collection date for primary outcome measure)
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:

-

Sex/Gender
Sexes Eligible for Study: All
Ages 5 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03435198
Other Study ID Numbers 0817.5f
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Evan Los, East Tennessee State University
Study Sponsor East Tennessee State University
Collaborators Mountain States Health Alliance
Investigators
Principal Investigator: Evan Los, MD East Tennessee State Univerisity
PRS Account East Tennessee State University
Verification Date February 2019