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
  Purpose

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
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Beijing Institute of Technology:

Primary Outcome Measures:
  • 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.


Enrollment: 389
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   35 Years to 72 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01902316

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

No publications provided

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
Study First Received: July 15, 2013
Last Updated: July 17, 2013
Health Authority: China: Ministry of Science and Technology

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

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

ClinicalTrials.gov processed this record on October 21, 2014