Assessement of the Diagnostic Interest in Insulin Resistance of the Specific and Quantitative ELISA Assay of a Plasma Biomarker of Cellular Glucose Capture: the Secreted IRAP Protein (Regulated Amino Peptidase Insulin)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 6
- 主要终点
- IRAP concentration during OGTT.
研究概览
简要总结
There is currently no reliable, diagnostic tests of insulin resistance other than the hyperinsulinemic euglycemic clamp which, due to its constraints and cost, is reserved for research. The insulin-Regulated aminopeptidase (IRAP) protein is a direct marker of insulin-dependent glucose cell capture and thus it blood concentration seems to be a good diagnostic test of insulin resistance.
The purpose of this study is to assess a plasma essay of IRAP protein for evaluation of insulin resistance during an oral glucose tolerance test (OGTT).
详细描述
This study consists of two visits, from three to fifteen days apart. Patients with different levels of insulin resistance will be enrolled in this study.
The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp that will be performed at the second visit.
The first visit :
- Subjects will be on an empty stomach
- A blood test including HbA1C, C-Peptid, lipid profile, creatinine,urea, hepatic workup
- An oral glucose tolerance test (OGTT) of 3 hours will be performed. Blood samples will be taken two time (T-15', T0) 15 minutes apart at Baseline (before taking the glucose). And then after the glucose intake, blood sample will be taken every 15 minutes (T15', T30', T 45', T60', T75', T90', T105', T120' and 180') to measure insulinemia, blood sugar, and IRAP concentration.
The second visit includes a 3-hours hyperinsulinemic euglycemic clamp.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient without known diabetes
- •Abdominal perimeter greater than 80 cm for women and greater than 94 cm for men
- •Patient affiliated to social security insurance or beneficiary of social security insurance.
- •Signed consent
排除标准
- •Consumption of narcotic
- •Medication that may interfere with glucose metabolism
- •History of bariatric surgery
- •Known acute or chronic renal insufficiency
- •Hyperinsulinemic euglycemic clamp contraindication
- •Contraindications with insulin, G20 glucose and Di-potassium phosphate
- •Histories of coronary pathology
- •History of heart rhythm disorders requiring chronic treatment
- •Period of fast
- •Pregnant women
结局指标
主要结局
IRAP concentration during OGTT.
时间窗: At the first visit (Day 0)
The level of insulin resistance will be estimated with a hyperinsulinemic euglycemic clamp. The specificity and sensitivity of the IRAP concentration for the diagnosis of insulin resistance will be determined at every time of the OGTT.
次要结局
- Kinetic profile of IRAP concentration in 3-hours OGTT(At the first visit (Day 0))
- Diagnostic value of the concentration of other biomarkers (not yet determined)(During the first visit (Day 0))
- Diagnostic value of IRAP(At the first visit (Day 0))