Exogenous Glucose Oxidation Breath Test (EGOBT)

National University of Ireland, Galway, Ireland

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: Oral glucose breath test

Study type: Interventional

Funder types: Other

Identifiers

NCT01846767

13CGLU

Details and patient eligibility

About

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

Full 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).

Enrollment: 46 patients

Sex: Male

Ages: 35 to 82 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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46 participants in 2 patient groups

Type 2 diabetes

Experimental group

Description:

Diabetic patients Oral glucose breath test

Treatment:

Other: Oral glucose breath test

Healthy controls

Experimental group

Description:

non-diabetic Oral glucose breath test

Treatment:

Other: Oral glucose breath test