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Clinical Trials in China / NCT06097065
Recruiting Observational

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

NCT06097065 · tracked via the Priya Life Science China tracker
Sponsor
Zhujiang Hospital
Phase
Observational
Started
2022-05-20
Last updated
2023-10-24

Condition(s) studied

PrediabetesDiabetes MellitusGestational Diabetes MellitusProteomics

Investigational drug(s) / intervention(s)

Oral Glucose Tolerance Test

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

Study 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.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
Accepted
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. \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06097065 on ClinicalTrials.gov ↗ ← All trials in China