Exogenous Glucose Oxidation Breath Test

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Oral glucose breath test

• Registration Number: NCT01846767
• Lead Sponsor: National University of Ireland, Galway, Ireland

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).

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2013-05-01
• Study First Submitted QC: 2013-05-01
• Study First Posted: 2013-05-03
• Primary Completion: 2013-12
• Study Completion: 2014-10
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-25
• Last Update Posted: 2014-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Type 2 diabetes	Oral glucose breath test	Diabetic patients Oral glucose breath test
Healthy controls	Oral glucose breath test	non-diabetic Oral glucose breath test

Primary Outcome Measures

Name	Time	Method
Peak Delta over baseline in 13CO2 breath enrichment	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Physiology laboratory; 🇮🇪 Galway, Ireland