Exploring biomarkers for prediabetes and diabetes using MALDI-TOF MS technology

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

This study is trying to find new markers in blood and urine samples that can help doctors better diagnose prediabetes and diabetes in different groups of people, including pregnant women.

Quick facts

• Study type: Observational
• Enrollment: 2860 (estimated)
• Sex: All
• Sponsor: Zhujiang Hospital (other)
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06097065 on ClinicalTrials.gov

What this trial studies

This observational study aims to investigate the differences in proteomics and peptidomics between fasting serum/plasma and urine samples from individuals with normal glucose tolerance and those with prediabetes or diabetes, as well as pregnant individuals with and without gestational diabetes. By utilizing the MALDI-TOF MS platform, the study seeks to identify potential new diagnostic markers for prediabetes and diabetes. The goal is to establish a clinical predictive diagnostic model based on these differences, which could enhance the accuracy of diagnosing these conditions.

Who should consider this trial

Good fit: Ideal candidates include individuals with prediabetes, diabetes, or gestational diabetes, as well as healthy controls with normal glucose tolerance.

Not a fit: Patients who do not have any form of glucose metabolism disorder or those who are not pregnant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic methods for prediabetes and diabetes, allowing for earlier intervention and better management of these conditions.

How similar studies have performed: While the approach of using MALDI-TOF MS for biomarker discovery is established, the specific application to differentiate prediabetes and diabetes in this manner is relatively novel.

Eligibility criteria

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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Where this trial is running

Guangzhou, Guangdong

• Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Nianyi Zeng

Conditions: Prediabetes, Diabetes Mellitus, Gestational Diabetes Mellitus, Proteomics