Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Clinical Verification for Early Diagnosis of Type 2 Diabetes Mellitus by Standard-Free, Label-Free LC-MS/MS Quantification of Glycated Peptides

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01902316
• Other study ID #: deng01
• Status: Completed
• Phase: N/A
• First received: July 15, 2013
• Last updated: July 17, 2013
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: July 2013
• Source: Beijing Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 72 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Institute of Technology

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measurement of the amount of plasma peptides	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	No