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临床试验/NCT01902316
NCT01902316已完成不适用

Clinical Verification for Early Diagnosis of Type 2 Diabetes Mellitus by Standard-Free, Label-Free LC-MS/MS Quantification of Glycated Peptides

Beijing Institute of Technology0 个研究点目标入组 389 人开始时间: 2009年1月最近更新:
适应症

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:

  1. to get plasma samples from hospital;
  2. digestion of plasma protein-mixture by trypsin;
  3. 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

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

发起方
Beijing Institute of Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yulin Deng

Dean of School of Life Science

Beijing Institute of Technology

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