Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.

October 18, 2023 updated by: Zhujiang Hospital
Through the MALDI-TOF MS platform, explore the proteomics and peptidomics differences of fasting serum/plasma and urine between non pregnant people with normal glucose tolerance test and prediabetes /diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively; To explore the role of its proteomics and peptidomics differences in the diagnosis of prediabetes and diabetes, and to establish a new method of differential diagnosis by using the omics data and key characteristic peaks to find potential new diagnostic markers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Prediabetes is a stage of abnormal glucose metabolism between normal blood glucose level and diabetes, which is a "gray zone" between normal and abnormal, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology between non pregnant people with normal glucose tolerance test and prediabetes/diabetes patients, pregnant people with normal glucose tolerance test and pregnant diabetes patients respectively and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.

Study Type

Observational

Enrollment (Estimated)

2860

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hongwei Zhou, Professor
  • Phone Number: +86 18688489622
  • Email: hzhou@smu.edu.cn

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

(1) cases: Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients; Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients. (2) controls: (Non)pregnant people: the remaining fasting serum/plasma and urine samples of normal population.

Description

Inclusion Criteria:

  1. Inclusion criteria for cases:

    Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients (prediabetes: IFG: FPG 6.1-6.9mmol/L, Blood glucose 2h after meal<7.8mmol/L（WHO）; IGT: FPG<7.0mmol/L, Blood glucose 2h after meal 7.8-11.1mmol/L（WHO）; diabetes: Typical symptoms of diabetes, FPG >= 7.0mmol/L or 75g OGTT 2h blood glucose >= 11.1mmol/L).

    Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients (75g OGTT test FPG >= 5.1mmol/L or 1h blood glucose >= 10.0mmol/L or 2h blood glucose >= 8.5mmol/L（IADPSG; ADA)).

  2. Inclusion criteria of the controls were as follows:

Non pregnant people: the remaining fasting serum/plasma and urine samples of normal population for glucose tolerance test (FPG 3.9-6.1mmol/L,75g OGTT test 1h blood glucose 6.7-11.1mmol/L,75g OGTT test 2h blood glucose 3.6-7.8mmol/L).

Pregnant people: the remaining fasting serum/plasma and urine samples of people who do not meet the diagnostic criteria for gestational diabetes (3.9<=75g OGTT test FPG<5.1mmol/L,6.7 <= 1h blood glucose<10.0mmol/L,3.6<=2h blood glucose<8.5mmol/L).

-

Exclusion Criteria:

Common exclusion criteria for cases and control were as follows: The sample volume of serum/plasma/urine is less than 300ul; Improper storage of samples or repeated freezing and thawing; The serum /plasma has obvious hemolysis, lipemia or jaundice.

-

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Non pregnant people with prediabetes or diabetes
Non pregnancy meeting the diagnosis of prediabetes or diabetes.
Diagnostic test: Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.
Non pregnant people with normal glucose tolerance
Non pregnant population with normal Oral Glucose Tolerance Test results.
Diagnostic test: Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.
pregnant people with gestational diabetes mellitus
Pregnant people who meet the diagnosis of gestational diabetes.
Diagnostic test: Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.
pregnant people with normal glucose tolerance
Pregnant people with normal Oral Glucose Tolerance Test results.
Diagnostic test: Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number and types of proteins/peptides differential characteristic peaks
Time Frame: one year
Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ROC curve and area under curve AUC of clinical predictive diagnostic model
Time Frame: one year
Construct a clinical predictive diagnostic model based on the obtained proteins/peptides differential feature peaks and calculate the area under the ROC curve AUC to evaluate the predictive effect of the model.
one year

Collaborators and Investigators

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

Sponsor

Zhujiang Hospital

Investigators

  • Study Chair: Hongwei Zhou, Professor, Zhujiang Hospital

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 (Actual)

May 20, 2022

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

October 9, 2023

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 24, 2023

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhujiangzx

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe