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Exogenous Glucose Oxidation Breath Test (EGOBT)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
Ireland
Study Type
Interventional
Intervention
Oral glucose breath test
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2 focused on measuring 13CO2, Breath test, Glucose oxidation, Diabetes mellitus

Eligibility Criteria

35 Years - 82 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Physiology laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Type 2 diabetes

Healthy controls

Arm Description

Diabetic patients Oral glucose breath test

non-diabetic Oral glucose breath test

Outcomes

Primary Outcome Measures

Peak Delta over baseline in 13CO2 breath enrichment
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 Outcome Measures

Per cent dose recovered
The per cent dose recovered of 13C glucose at 240 minutes.

Full Information

First Posted
May 1, 2013
Last Updated
November 25, 2014
Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Endocrine Society
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1. Study Identification

Unique Protocol Identification Number
NCT01846767
Brief Title
Exogenous Glucose Oxidation Breath Test
Acronym
EGOBT
Official Title
Study of the Metabolism of 13C Labelled Glucose to 13CO2 in Human Breath
Study Type
Interventional

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Ireland, Galway, Ireland
Collaborators
Irish Endocrine Society

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
13CO2, Breath test, Glucose oxidation, Diabetes mellitus

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Type 2 diabetes
Arm Type
Experimental
Arm Description
Diabetic patients Oral glucose breath test
Arm Title
Healthy controls
Arm Type
Experimental
Arm Description
non-diabetic Oral glucose breath test
Intervention Type
Other
Intervention Name(s)
Oral glucose breath test
Intervention Description
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.
Primary Outcome Measure Information:
Title
Peak Delta over baseline in 13CO2 breath enrichment
Description
The peak enrichment of 13CO2 in breath is calculated by identifying the highest abundance breath sample and subtracting the base line abundance from it.
Time Frame
at 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after glucose ingestion.
Secondary Outcome Measure Information:
Title
Per cent dose recovered
Description
The per cent dose recovered of 13C glucose at 240 minutes.
Time Frame
240 minutes
Other Pre-specified Outcome Measures:
Title
Diabetes classifications and measures of insulin resistance
Description
Fasting 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.
Time Frame
0 and 120 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
82 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amir Shafat, PhD
Organizational Affiliation
National University of Ireland, Galway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Physiology laboratory
City
Galway
ZIP/Postal Code
11111
Country
Ireland

12. IPD Sharing Statement

Citations:
PubMed Identifier
9266210
Citation
Rating D, Langhans CD. Breath tests: concepts, applications and limitations. Eur J Pediatr. 1997 Aug;156 Suppl 1:S18-23. doi: 10.1007/pl00014264.
Results Reference
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PubMed Identifier
10994620
Citation
Stellaard F, Koetse HA, Elzinga H, Boverhof R, Tjoonk R, Klimp A, Vegter D, Liesker J, Vonk RJ. 13C-carbohydrate breath tests: impact of physical activity on the rate-limiting step in lactose utilization. Scand J Gastroenterol. 2000 Aug;35(8):819-23. doi: 10.1080/003655200750023183.
Results Reference
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PubMed Identifier
3143819
Citation
Lifschitz CH, Boutton TW, Carrazza F, Beyreiss K, Schmitz J, Ricour C, Shulman R, Nichols BL. A carbon-13 breath test to characterize glucose absorption and utilization in children. J Pediatr Gastroenterol Nutr. 1988 Nov-Dec;7(6):842-7. doi: 10.1097/00005176-198811000-00008.
Results Reference
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PubMed Identifier
20507559
Citation
Mizrahi M, Lalazar G, Adar T, Raz I, Ilan Y. Assessment of insulin resistance by a 13C glucose breath test: a new tool for early diagnosis and follow-up of high-risk patients. Nutr J. 2010 May 27;9:25. doi: 10.1186/1475-2891-9-25.
Results Reference
background
PubMed Identifier
19074994
Citation
Dillon EL, Janghorbani M, Angel JA, Casperson SL, Grady JJ, Urban RJ, Volpi E, Sheffield-Moore M. Novel noninvasive breath test method for screening individuals at risk for diabetes. Diabetes Care. 2009 Mar;32(3):430-5. doi: 10.2337/dc08-1578. Epub 2008 Dec 15.
Results Reference
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Exogenous Glucose Oxidation Breath Test

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