Assessment of Insulin Sensitivity in Healthy Adults by a 13C-glucose Breath Test : Method Development and Validation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- 1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test
研究概览
简要总结
The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system.
Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.
详细描述
The current research project aims to assess the insulin resistance (less sensitivity), from measures of insulin and glucose in response to a standard oral intake of glucose (standardized oral glucose tolerance test). For this, we wish to test and validate the method of glucose labelled 13-C (stable isotope) breath test in comparison with standardized methods to measure glucose and insulin. Comparative methods that will be used are measures of glycemia from venous blood withdrawal and continuous glucose measurement in the skin tissue (external face of the arm) using the Abbott's freestyle libre system.
Repeatability and reliability of the 13-C glucose breath test will be checked from repeated measures over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male adults aged 18-40 Able to understand and to sign a written informed consent
排除标准
- •EXCLUSION CRITERIA
- •Known type 1 or type 2 diabetes, by anamnesis
- •Family history of type 2 diabetes (parents)
- •History of gestational diabetes
- •Any other metabolic disease possibly impacting the postprandial glucose and insulin response (anamnesis)
- •Any medication impacting the energetic metabolism, to the opinion of the investigator
- •Pregnant or lactating women (anamnesis)
- •Allergy or intolerance to any food or compound used in this study
- •Currently following a strict exercise program (more than three times per week) in order to either lose weight, gain muscle or reach competition standards for a chosen sport
- •Having given blood in the past three months or willing to give blood in the 3 months following the completion of the study
- •Currently participating or having participated in another clinical trial during the past month.
- •Volunteer who cannot be expected to comply with the protocol
结局指标
主要结局
1) To assess the within-subjects variability and overall repeatability of the 13C-glucose breath test
时间窗: 0 to 300 minutes, after oral administration
repeated measure of breath over the 3 visits.
次要结局
- Compare the results of breath test and CGM with the classical indexes of insulin resistance after an oral glucose challenge (OGTT) containing a small amount of [U13C]-glucose.(0 to 300 minutes, after oral adminstration)
- Repeatability of the continuous glucose monitoring system (CGM)(0 to 300 minutes, after oral adminstration)