Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

July 17, 2013 updated by: Yulin Deng, Beijing Institute of Technology

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.

Study Overview

Status

Completed

Conditions

Diabetes Mellitus, Type 2

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

389

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 72 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Institute of Technology

Investigators

Principal Investigator: Yulin Deng, Ph.D., School of Life Science, BIT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

July 15, 2013

First Submitted That Met QC Criteria

July 17, 2013

First Posted (Estimate)

July 18, 2013

Study Record Updates

Last Update Posted (Estimate)