Salivary Transcriptome Biomarkers for Early Diabetes Detection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- A multi marker test score based on a pre-specified model is measured in each patient. The test score is on a scale of 0 to 1.0 and relates to the probability of disease.
研究概览
简要总结
A PRoBE design study will be used to obtain saliva from patients before undergoing blood study evaluation for screening at risk patients for the presence of undiagnosed pre-diabetes of type II diabetes. Pre-specified saliva biomarkers will be evaluated along with multi-marker models for their discriminatory value for distinguishing patients with normal glucose metabolism from those with disease. Appropriate housekeeping genes will also be incorporated to allow for the measurement of relative gene expression.
详细描述
Prospective-specimen-collection, retrospective-blinded-evaluation (PRoBE) methods will be employed to collect saliva and evaluate transcriptome markers for early pre-diabetes and type II diabetes identification. At risk patients will have fasting blood glucose and insulin levels measured along with hemoglobin A1c and 2 hour post-prandial glucose levels. Saliva samples will be stored and will be analyzed after pre-specifying a panel of mRNAs and a multi marker model for validation. The pre-specified mRNAs and multi-marker model will be determined after analysis of data from a currently ongoing case-control study. After analyzing the data from this prior trial a validation plan will be locked before analysis of the prospectively collected specimens. Pre-diabetes will be defined based on abnormal glucose tolerance tests. Insulin resistance will be calculated as HOMA IR. The diagnostic value of the salivary transcriptome for will be compared with that of hemoglobin A1c and fasting blood glucose for the detection of pre-diabetes, insulin resistance and type II diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients with unknown glucose metabolism status and
- •Requiring clinically driven screening for abnormal glucose metabolism and
- •Outpatient status
排除标准
- •Patients on treatment for abnormal glucose metabolism including diet and drug therapy
- •Patients with a prior diagnosis of abnormal glucose metabolism
- •Patients on treatment with corticosteroids
结局指标
主要结局
A multi marker test score based on a pre-specified model is measured in each patient. The test score is on a scale of 0 to 1.0 and relates to the probability of disease.
时间窗: At study entry
The area under the ROC curve is used to determine the overall performance of the model at the completion of the study. An area over 0.7 is considered clincially significant.
次要结局
- Pre-specified mRNA marker Ct values from PCR analysis will be measured in individual patients(At study entry)
- Housekeeping gene Ct values on PCR analysis will be measured in individual patients(At study entry)