NCT01846767已完成不适用
Study of the Metabolism of 13C Labelled Glucose to 13CO2 in Human Breath
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Peak Delta over baseline in 13CO2 breath enrichment
研究概览
简要总结
The purpose of this study is to determine if oxidation of 13C glucose to 13CO2 is changed in type 2 diabetic patients.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 35 Years 至 82 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Peak Delta over baseline in 13CO2 breath enrichment
时间窗: 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.
次要结局
- Per cent dose recovered(240 minutes)
研究者
Amir Shafat
Dr
National University of Ireland, Galway, Ireland
研究点 (2)
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