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Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01902316
Recruitment Status : Completed
First Posted : July 18, 2013
Last Update Posted : July 18, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease
Diabetes Mellitus, Type 2

Detailed Description:

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.

Study Design

Study Type : Observational
Actual Enrollment : 389 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Clinical Verification for Early Diagnosis of Type 2 Diabetes Mellitus by Standard-Free, Label-Free LC-MS/MS Quantification of Glycated Peptides
Study Start Date : January 2009
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 72 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
university hospital, plasma samples of physical examination, faculties and staff of a certain university
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01902316


Sponsors and Collaborators
Beijing Institute of Technology
Investigators
Principal Investigator: Yulin Deng, Ph.D. School of Life Science, BIT
More Information

Responsible Party: Yulin Deng, Dean of School of Life Science, Beijing Institute of Technology
ClinicalTrials.gov Identifier: NCT01902316     History of Changes
Other Study ID Numbers: deng01
First Posted: July 18, 2013    Key Record Dates
Last Update Posted: July 18, 2013
Last Verified: July 2013

Keywords provided by Yulin Deng, Beijing Institute of Technology:
Type 2 Diabetes Mellitus
peptide biomarker
early diagnosis
label free

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases