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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01902316

Enrollment

389

Registered

2013-07-18

Start date

2009-01-31

Completion date

2011-12-31

Last updated

2013-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 Diabetes Mellitus, peptide biomarker, early diagnosis, label free

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.

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 72 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
measurement of the amount of plasma peptides	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.

Outcome results