Investigation of Urinary Biomarkers for the Diagnosis of Insulin Resistance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 304
- 试验地点
- 2
- 主要终点
- Correlation between urinary levels of BCAAs and HOMA index
研究概览
简要总结
The study aims at the identification and the quantification of urinary branched-chain amino acids (BCAAs) by mass spectometry in healthy subjects and patients with insulin resistance and correlating urinary BCAAs with HOMA index.
Blood and urine levels of BCAAs will be correlated with HOMA index to assess and quantify insulin resistance.
Identification and quantification of urine BCAAs by an innovative method based on synthetic biology will also be performed.
Correlations between mass spectometry and the innovative detection method of BCAAs will be searched.
详细描述
Blood and urine samples will be collected in 330 persons to assess BCAAs levels and correlate them with HOMA index.
Persons included will be:
110 persons with BMI>27 and HOMA >4 with no diabetes 110 persons with BMI>27 and HOMA < 4 with no diabetes 110 persons with BMI < 27 and HOMA <4 with no diabetes, including at least 50 men and 50 women, 30 aged 18-35, 30 aged 36-55, 30 aged 56-75.
Urine BCAAs will be measured by both mass spectrometry and the innovative method based on synthetic biology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •no diabetes
- •according to studied subpopulations: BMI<27 and HOMA <4, BMI>27 and HOMA>4, BMI>27 and HOMA<4
排除标准
- •pregnancy or lactation
- •active or suspected chronic infection
- •treatment affecting insulin sensitivity
结局指标
主要结局
Correlation between urinary levels of BCAAs and HOMA index
时间窗: through study completion, an average of two years and a half
Identification of urinary BCAAs as markers of insulin resistance
次要结局
- Correlation between blood and urine BCAAs levels(through study completion, an average of two years and a half)
- Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and classic method(through study completion, an average of two years and a half)
- Correlation between urine BCAAs levels measured by enzymatic method (artificial vesicles) and HOMA index(through study completion, an average of two years and a half)