Status:
RECRUITING
Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.
Lead Sponsor:
Zhujiang Hospital
Conditions:
Prediabetes
Diabetes Mellitus
Eligibility:
All Genders
Brief 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 /...
Detailed 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), imp...
Eligibility Criteria
Inclusion
- 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)).
- 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
- 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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Key Trial Info
Start Date :
May 20 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
2860 Patients enrolled
Trial Details
Trial ID
NCT06097065
Start Date
May 20 2022
End Date
December 31 2026
Last Update
October 24 2023
Active Locations (1)
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1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510000