Determining of Normal Values and Conformity Assessment of the Dosage of a Plasmatic Specific Marker of the Cellular Captation of Glucose: the IRAP Protein (Insulin Regulated AminoPeptidase)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line.
研究概览
简要总结
The purpose of this study is on one hand to verify the measurement conformity of the IRAP dosage and on the other hand to obtain normal values of the blood IRAP concentration on healthy volunteers.
详细描述
This study consists of two visits, from two to five days apart.
The first visit :
- Healthy volunteers will be on an empty stomach.
- they will have a clinical examination, blood tests and blood samples will be taken to constitute a blood collection. the IRAP concentration will be measured with those samples.
The second visit : This visit will take place in an interval from 2 to 5 days after the first visit.
- Subjects will be on an empty stomach
- An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken three time 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes to measure insulinemia, blood glucose, and IRAP concentration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index between 19 and 25 Kg/m²
- •No intercurrent disease during the last week
- •No chronic infectious disease
- •No smoker, no alcoholic
排除标准
- •history of : thyroid disease, liver or renal disease, endocrine and metabolic disease, cardiovascular disease, lung disease, gastroenterological disorders, psychiatric disease, Epilepsy
- •Consumption of narcotic drug
- •Blood donation dating less than 2 months
- •Pregnancy or breast-feeding, or intent to become pregnant during the study period
- •legal exclusion criteria
结局指标
主要结局
Normal values of IRAP concentration will be calculated by making the average of the three dosages of IRAP measured at base line.
时间窗: At the beginning of the second visit of the study, before the glucose intake
Three blood samples will be taken 15 minutes apart, before the OGTT. The average of IRAP concentration measured with those 3 samples, will be used to assess the normal values of IRAP concentration on a healthy population.
次要结局
- Temporal reproducibility of the concentration of IRAP(At the beginning of the second visit of the study, before the glucose intake)
- Repeatability of the IRAP measurement(At the beginning of the second visit of the study, before the glucose intake)