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Completed

NCT Number: NCT01902316

Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Type 2 Diabetes Mellitus cases;
  • Impaired Glucose Tolerance cases;
  • Normal Glucose Tolerance cases

Exclusion criteria

  • Type 1 Diabetes Mellitus cases;
  • Gestational Diabetes Mellitus cases;
  • Hepatitis patients

Treatment and study plan

Primary outcomes

  1. measurement of the amount of plasma peptides

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Beijing Institute of Technology

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 18, 2013
Registry last updated
Jul 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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