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Exogenous Glucose Oxidation Breath Test

Study of the Metabolism of 13C Labelled Glucose to 13CO2 in Human Breath

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01846767
Acronym
EGOBT
Enrollment
46
Registered
2013-05-03
Start date
2012-04-30
Completion date
2014-10-31
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

13CO2, Breath test, Glucose oxidation, Diabetes mellitus

Brief summary

The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients.

Detailed description

Recruitment \- Non diabetic participants will be recruited from within the National University of Ireland, Galway student and staff community. Diabetic patients will be recruited from University College Hospital, Galway in collaboration with their hospital consultant. Test- day \- They will undergo two separate, identical and simultaneous Oral Glucose Tolerance test and 13C-glucose breath tests on two separate occasions after an overnight fast of 12 hours starting at 8pm. On arrival their heart rate, blood pressure, height and weight will be recorded. Following a resting period of 10 minutes, samples will be obtained for fasting glucose and breath enrichment values (at t = -20 and -10mins). At t = 0 min, participants will consume a standard glucose solution. This glucose solution will consist of 150mg of 13C-glucose, 74.85g of glucose and 200ml of water and 25ml of orange flavoring. Breath samples will be obtained immediately after consumption of test solution and repeated every 15 min over a 4-h interval. Blood glucose concentrations will be taken every 15 min starting at t = 15 min, over a 2-h interval and every 30 min for another 2-h interval. Participants will remain at rest throughout the study. Sample size assessment \- Target recruitment is 40 non-diabetics and 40 diabetic participants. This study will use a Student's t-test to determine difference, or otherwise, in glucose oxidation in breath 13CO2, in 2 different groups of individuals. With power arbitrarily set at 0.8, effect size of 1.21 reduction in breath, and Alpha set at 0.01 a final number of 35 participants is required for each group. The n=40 for each group is set to allow a 5 participant drop out in each group Dillon et al (2009).

Interventions

OTHEROral glucose breath test

Simultaneous oral glucose tolerance test and exogenous 13C-glucose breath test following a 12hr overnight fast. Fasting samples were obtained for plasma glucose, insulin, c-peptide, leptin, adiponectin, resistin, HbA1c and two breath 13CO2 abundance values (at t = -15 and -5min). At t = 0min, each subject drank a 75g glucose solution (Thornton & Ross, UK) containing 0.15g of 1-13C glucose. Further breath samples (every 15 min over a 240min interval) and further plasma blood glucose, insulin and c-peptide samples (90,120,180min) were also taken.

Sponsors

Irish Endocrine Society
CollaboratorOTHER
National University of Ireland, Galway, Ireland
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
35 Years to 82 Years
Healthy volunteers
Yes

Inclusion criteria

* All research participants must be between 18 and 65 years * Non-diabetic participants must not be taking any medication for diabetes * Participants must speak English or Irish proficiently * All participants must be males * All participants must live within Galway City * Type 2 diabetic participants must have been diagnosed within the last five years * Type 2 diabetic participants must be treated by Metformin alone for their diabetes * All participants must provide written informed consent to comply with every aspect of the study

Exclusion criteria

* Females

Design outcomes

Primary

MeasureTime frameDescription
Peak Delta over baseline in 13CO2 breath enrichmentat 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after glucose ingestion.The peak enrichment of 13CO2 in breath is calculated by identifying the highest abundance breath sample and subtracting the base line abundance from it.

Secondary

MeasureTime frameDescription
Per cent dose recovered240 minutesThe per cent dose recovered of 13C glucose at 240 minutes.

Other

MeasureTime frameDescription
Diabetes classifications and measures of insulin resistance0 and 120 minutesFasting plasma glucose and glucose tolerance at 120min, as defined by plasma glucose concentrations. Also measured Leptin/Adiponectin concentrations, Fasting insulin, calculated homeostatic model assessment and and quantitative insulin sensitivity check index.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026