Evaluation of Plasma IRAP Secreted Protein as a New Insulin Sensitivity Biomarker, Using Hyperinsulinemic Euglycemic Clamp
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
研究概览
简要总结
Previous studies have demonstrated defects in the trafficking and translocation of GLUT4 glucose transporter in skeletal muscle and adipose tissue to be a major cause of insulin resistance in humans. IRAP (Secreted Insulin Regulated AminoPeptidase) is a protein which collocalizes and is translocated with GLUT4 to the plasma membrane in response to insulin. The extracellular domain of IRAP is cleaved and released in the bloodstream.
Therefore, IRAP plasma concentration could be a good marker of insulin sensitivity.
In this study the investigators seek to confirm this hypothesis by using the gold standard of insulin sensitivity assessment: the hyperinsulinemic-euglycemic clamp.
It is a multicenter descriptive study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women (sex ratio = 1)
- •Aged from 18 to 35 years
- •Fasting glycemia < 6mmol/L
- •Total cholesterol < 7mmol/L
- •Triglycerides < 1.5 mmol/L
- •CRPus < 5 mg/L
- •Creatinine clearance < 80mL/min according to Cockroft formula
- •Liver enzymes (ALanine AminoTransférase and ASpartate AminoTransférase) < 1.5 times normal values
排除标准
- •Subject not in compliance with the recommendations of French National Law in force
- •Medical history of metabolic disease (diabetes, dyslipidemia), endocrine disease, renal insufficiency
- •Drug use that could affect glucose metabolism and the renin angiotensin aldosterone system
- •Blood pressure > 140/90mmHg
- •Tea and coffee consumption more than 5 cups per day
- •Subject who smoke more than 5 cigarettes per day
结局指标
主要结局
IRAP plasma concentration during the hyperinsulinemic euglycemic clamp
时间窗: 30 min before the clamp and during the clamp every 10 min for a duration of 240 min.
Enzyme-linked Immunosorbsent assay (Sandwich ELISA)
次要结局
- Glucose Infusion Rate (GIR)(at T90, T100, T110, T120 minutes and T210, T220, T230, T 240 minutes)
- Oxydative stress markers(at T0, T120 and T240 min)