Biomarkers in Exhaled Breath of Glucose Fluctuation in Type 1 Diabetes

NCT03435198 | Completed

• 1 other identifier: 0817.5f
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Volatile Organic Compounds; Hypoglycemia; Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (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.

  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

  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.

  up to 1 month

• Identify differences in patterns of exhaled VOCs in people who have hypoglycemia unawareness

  up to 1 month

Interventions

Collect exhaled breath during low and normal blood sugar DIAGNOSTIC_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.

Eligibility Criteria

• Age: 5 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People with type 1 diabetes between age 5-80.

You may qualify if:

• 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

Sponsors & Collaborators

• East Tennessee State University: lead
• Mountain States Health Alliance: collaborator

Study Sites (1)

Mountain States Health Alliance

Johnson City, Tennessee, 37604, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

human breath samples collected in sealed bags and shipped to receiving/processing lab. Once processed, samples are destroyed.

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Evan Los, MD

  East Tennessee State Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 15, 2018
• Study Start: March 1, 2018
• Primary Completion: August 30, 2018
• Study Completion: August 30, 2018
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)