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

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: Diabetes Mellitus; Prediabetes; Gestational Diabetes Mellitus; Proteomics
• Intervention / Treatment: Diagnostic test: Oral Glucose Tolerance Test

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

• Study Contact: Name: Nianyi Zeng; Phone Number: +86 13928801657; Email: zengny1@i.smu.edu.cn
• 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: Nianyi Zeng; Phone Number: +86 13928801657; Email: zengny1@i.smu.edu.cn

Participation Criteria

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).

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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.

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Study Plan

How is the study designed?

Number of groups / cohorts

4

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	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	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

• Sponsor: Zhujiang Hospital
• Investigators: Study Chair: Hongwei Zhou, Professor, Zhujiang Hospital

Study record dates

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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Pregnancy Complications; Hyperglycemia; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Prediabetic State; Glucose Intolerance; Diabetes, Gestational
• 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