Clinical Verification for Early Diagnosis of Type 2 Diabetes Mellitus by Standard-Free, Label-Free LC-MS/MS Quantification of Glycated Peptides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 389
- 主要终点
- measurement of the amount of plasma peptides
研究概览
简要总结
Although diabetes has been controlled since insulin became available, it is still considered incurable and poses serious threats to human health. Reports have suggested that the hyperglycemic condition of patients with diabetes mellitus may be greatly alleviated or even reversed if it could be controlled at an early stage of diabetes. Thus, early detection and diagnosis of diabetes and prediabetes are become increasingly important in the treatment and prevention of diabetes. Diabetes mellitus is currently diagnosed by recurrent or persistent hyperglycemia. In an effort to identify novel biomarkers for diabetes, research has shown that neither plasma glucose nor glycated hemoglobin (HbA1c) levels are unable to be used in the early detection of diabetes. In this work, the investigators have found 8 biomarker candidates by developing a standard-free, label-free MS-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference between normal people and diabetes patients.
详细描述
The procedure of clinical study was:
- to get plasma samples from hospital;
- digestion of plasma protein-mixture by trypsin;
- run mass spectrometry and monitor the amount of target HSA-peptides.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 35 Years 至 72 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 Diabetes Mellitus cases;
- •Impaired Glucose Tolerance cases;
- •Normal Glucose Tolerance cases
排除标准
- •Type 1 Diabetes Mellitus cases;
- •Gestational Diabetes Mellitus cases;
- •Hepatitis patients
结局指标
主要结局
measurement of the amount of plasma peptides
时间窗: two years
The investigators have found 8 biomarker candidates by developing a standard-free, label-free MS-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. Then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference between normal people and diabetes patients.
次要结局
未报告次要终点
研究者
Yulin Deng
Dean of School of Life Science
Beijing Institute of Technology
