Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Yulin Deng, Beijing Institute of Technology
ClinicalTrials.gov Identifier:
NCT01902316
First received: July 15, 2013
Last updated: July 17, 2013
Last verified: July 2013

July 15, 2013
July 17, 2013
January 2009
December 2011   (final data collection date for primary outcome measure)
measurement of the amount of plasma peptides [ Time Frame: two years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01902316 on ClinicalTrials.gov Archive Site
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Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus
Clinical Verification for Early Diagnosis of Type 2 Diabetes Mellitus by Standard-Free, Label-Free LC-MS/MS Quantification of Glycated Peptides

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.

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.
Observational
Observational Model: Case-Only
Time Perspective: Retrospective
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Non-Probability Sample

university hospital, plasma samples of physical examination, faculties and staff of a certain university

Diabetes Mellitus, Type 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 72 Years
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01902316
deng01
Yes
Yulin Deng, Beijing Institute of Technology
Beijing Institute of Technology
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Principal Investigator: Yulin Deng, Ph.D. School of Life Science, BIT
Beijing Institute of Technology
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP