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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097065
• Other study ID #: Zhujiangzx
• Status: Recruiting
• Start date: May 20, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: Zhujiang Hospital
• Contact: Nianyi Zeng
• Phone: 13928801657
• Email: zengny1[@]i.smu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2860
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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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Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus
• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Proteomics

Intervention

Diagnostic Test:
• Oral Glucose Tolerance Test
Grouping based on detected oral glucose tolerance test results without any other intervention.

Locations

Country	Name	City	State
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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