Clinical Verification of Peptide Biomarkers for Type 2 Diabetes Mellitus

NCT01902316 | Completed DMC

• 1 other identifier: deng01
• Study Type: observational
• Target: 389
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 35 Years - 72 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Type 2 Diabetes Mellitus cases;
• Impaired Glucose Tolerance cases;
• Normal Glucose Tolerance cases

You may not qualify if:

• Type 1 Diabetes Mellitus cases;
• Gestational Diabetes Mellitus cases;
• Hepatitis patients

Sponsors & Collaborators

• Beijing Institute of Technology: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Disease

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yulin Deng, Ph.D.

  School of Life Science, BIT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of School of Life Science

Study Record Dates

• First Submitted: July 15, 2013
• First Posted: July 18, 2013
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 18, 2013

Record last verified: 2013-07