Diabetes Mellitus, Type 2EGOBTNCT01846767
Exogenous Glucose Oxidation Breath Test
A study testing Oral glucose breath test in people with Diabetes Mellitus, Type 2, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
Trial summary
The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 35 to 82 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Oral glucose breath test
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteIreland
- Study dates
- Apr 2012to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 82 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Metabolism of 13C Labelled Glucose to 13CO2 in Human Breath
The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients.
Read the 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).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Oral glucose breath test
- Keywords
- 13CO2, Breath test, Glucose oxidation, Diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral glucose breath testOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Type 2 diabetes | Experimental | Diabetic patients Oral glucose breath test Receives: Other: Oral glucose breath test |
| Healthy controls | Experimental | non-diabetic Oral glucose breath test Receives: Other: Oral glucose breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after glucose ingestion.
Secondary outcomes (1)
Per cent dose recovered
The per cent dose recovered of 13C glucose at 240 minutes.
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startApr 2012
- Primary completionDec 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Ireland, Galway, Ireland
- Sponsor type
- University, hospital or other
- Collaborators
- Irish Endocrine Society
- Responsible party
- Principal investigator, Amir Shafat, National University of Ireland, Galway, Ireland
- Investigators
- Amir Shafat, PhD, Principal investigator, National University of Ireland, Galway, Ireland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846767
- Sponsor's protocol ID
- 13CGLU
- Acronym
- EGOBT
- Status last verified
- Nov 2014
- First submitted
- 1 May 2013
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rating D, Langhans CD. Breath tests: concepts, applications and limitations. Eur J Pediatr. 1997 Aug;156 Suppl 1:S18-23. doi: 10.1007/pl00014264.
PubMed 9266210Stellaard 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.
PubMed 10994620Lifschitz 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.
PubMed 3143819Mizrahi 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.
PubMed 20507559Dillon 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.
PubMed 19074994
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Metabolism of 13C Labelled Glucose to 13CO2 in Human Breath
- ClinicalTrials.gov ID
- NCT01846767
- Acronym / sponsor ID
- EGOBT / 13CGLU
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- 13CO2, Breath test, Glucose oxidation, Diabetes mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National University of Ireland, Galway, IrelandUniversity, hospital or other
- Collaborators
- Irish Endocrine Society
- Study start
- Apr 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 2 diabetes | Experimental | Other: Oral glucose breath testDiabetic patients Oral glucose breath test |
| Healthy controls | Experimental | Other: Oral glucose breath testnon-diabetic Oral glucose breath test |
Who may qualify
- Ages
- 35 to 82 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Females
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral glucose breath testSimultaneous 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. | Other | Healthy controls, Type 2 diabetes |
Primary outcome
Peak Delta over baseline in 13CO2 breath enrichment
Time frame: at 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.
1 secondary outcome
Per cent dose recovered
Time frame: 240 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- Background: PubMed 9266210Rating D, Langhans CD. Breath tests: concepts, applications and limitations. Eur J Pediatr. 1997 Aug;156 Suppl 1:S18-23. doi: 10.1007/pl00014264.
- Background: PubMed 10994620Stellaard 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.
- Background: PubMed 3143819Lifschitz 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.
- Background: PubMed 20507559Mizrahi 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.
- Background: PubMed 19074994Dillon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Shafat, PhD principal investigator
National University of Ireland, Galway, Ireland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral glucose breath test in people with Diabetes Mellitus, Type 2, run by National University of Ireland, Galway, Ireland at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Delta over baseline in 13CO2 breath enrichment (time frame: at 0, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 195, 210, 225, 240 minutes after glucose ingestion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01846767, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.