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

Zhujiang Hospital

Status: Enrolling

Conditions: Prediabetes; Gestational Diabetes Mellitus; Diabetes Mellitus; Proteomics

Treatments: Diagnostic Test: Oral Glucose Tolerance Test

Study type: Observational

Funder types: Other

Identifiers

NCT06097065

Zhujiangzx

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,860 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

2,860 participants in 4 patient groups

Non pregnant people with prediabetes or diabetes

Description:

Non pregnancy meeting the diagnosis of prediabetes or diabetes.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

Non pregnant people with normal glucose tolerance

Description:

Non pregnant population with normal Oral Glucose Tolerance Test results.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

pregnant people with gestational diabetes mellitus

Description:

Pregnant people who meet the diagnosis of gestational diabetes.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test

pregnant people with normal glucose tolerance

Description:

Pregnant people with normal Oral Glucose Tolerance Test results.

Treatment:

Diagnostic Test: Oral Glucose Tolerance Test