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Search / Trial NCT06097065

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

Launched by ZHUJIANG HOSPITAL · Oct 18, 2023

Trial Information

Current as of July 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at how certain proteins and small molecules in the blood and urine differ between people with normal blood sugar levels and those with prediabetes or diabetes. The goal is to find new ways to diagnose prediabetes and diabetes using these differences. Researchers are using a special technique called MALDI-TOF MS to analyze these samples. By doing this, they hope to discover potential new markers that could help doctors identify these conditions more accurately.

To participate in the study, individuals must meet specific criteria. For example, non-pregnant participants should have fasting blood sugar levels that fall into the prediabetes or diabetes categories, while pregnant participants should have been diagnosed with gestational diabetes. Healthy individuals with normal blood sugar levels can also join as controls. Participants will be asked to provide blood and urine samples, and their contributions will help researchers better understand diabetes and improve diagnosis methods. If you're interested or think you might qualify, consider discussing it with your healthcare provider for more information.

Gender

ALL

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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About Zhujiang Hospital

Zhujiang Hospital, affiliated with the Southern Medical University in Guangzhou, China, is a leading clinical research institution dedicated to advancing medical science and improving patient care through rigorous clinical trials. With a strong commitment to ethical standards and patient safety, the hospital boasts a multidisciplinary team of experienced researchers and healthcare professionals. Its state-of-the-art facilities enable the execution of innovative studies across various therapeutic areas, contributing valuable insights to the global medical community. Zhujiang Hospital aims to foster collaboration with academic institutions, pharmaceutical companies, and regulatory bodies to ensure the successful development of new therapies and enhance treatment options for patients.

Locations

Guangzhou, Guangdong, China

Guangzhou, Guangdong, China

Patients applied

0 patients applied

Trial Officials

Hongwei Zhou, Professor

Study Chair

Zhujiang Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported