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

NCT ID: NCT06097065

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 2860 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-20
• Study Completion Date: 2026-12-31

Brief Summary

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.

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.

Conditions

Prediabetes; Diabetes Mellitus; Gestational Diabetes Mellitus; Proteomics

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Non pregnant people with prediabetes or diabetes

Non pregnancy meeting the diagnosis of prediabetes or diabetes.

Oral Glucose Tolerance Test

Intervention Type: DIAGNOSTIC_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.

Oral Glucose Tolerance Test

Intervention Type: DIAGNOSTIC_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.

Oral Glucose Tolerance Test

Intervention Type: DIAGNOSTIC_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.

Oral Glucose Tolerance Test

Intervention Type: DIAGNOSTIC_TEST

Grouping based on detected oral glucose tolerance test results without any other intervention.

Interventions

Oral Glucose Tolerance Test

Grouping based on detected oral glucose tolerance test results without any other intervention.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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)).

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

-

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongwei Zhou, Professor

Role: STUDY_CHAIR

Zhujiang Hospital

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Nianyi Zeng

Role: CONTACT

zengny1@i.smu.edu.cn

13928801657 ext. +86

Hongwei Zhou, Professor

Role: CONTACT

hzhou@smu.edu.cn

18688489622 ext. +86

Facility Contacts

Nianyi Zeng

Role: primary

zengny1@i.smu.edu.cn

13928801657 ext. +86

Other Identifiers

Zhujiangzx

Identifier Type: -

Identifier Source: org_study_id