NCT06097065 Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.
| NCT ID | NCT06097065 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Prediabetes |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,860 participants |
| Start Date | 2022-05-20 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,860 participants in total. It began in 2022-05-20 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 /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 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). \- 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. \-
Contact & Investigator
Hongwei Zhou, Professor
STUDY CHAIR
Zhujiang Hospital
Frequently Asked Questions
Who can join the NCT06097065 clinical trial?
This trial is open to participants of all sexes, studying Prediabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06097065 currently recruiting?
Yes, NCT06097065 is actively recruiting participants. Contact the research team at zengny1@i.smu.edu.cn for enrollment information.
Where is the NCT06097065 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06097065 clinical trial?
NCT06097065 is sponsored by Zhujiang Hospital. The principal investigator is Hongwei Zhou, Professor at Zhujiang Hospital. The trial plans to enroll 2,860 participants.
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