PrediabetesNCT06097065
Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.
An observational study of Prediabetes and Diabetes Mellitus, run by Zhujiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Prediabetes, Diabetes Mellitus, Gestational Diabetes Mellitus
- What is being tested?
- Oral Glucose Tolerance Test
- Type of treatment
- Pill or oral medicine
- How many people
- 2,860 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2022to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: (1) cases: Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients; Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients. (2) controls: (Non)pregnant people: the remaining fasting serum/plasma and urine samples of normal population.
Who may be able to join
- 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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Who cannot join
- 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.
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000
Nianyi Zeng, 13928801657 ext. +86, zengny1@i.smu.edu.cn
About this study
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.
Read the 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), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology 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 and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.
- Being tested
- Oral Glucose Tolerance Test
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Glucose Tolerance TestDiagnostic test
Grouping based on detected oral glucose tolerance test results without any other intervention.
| Study group | Role | What they receive |
|---|---|---|
| Non pregnant people with prediabetes or diabetes | Non pregnancy meeting the diagnosis of prediabetes or diabetes. Receives: Diagnostic Test: Oral Glucose Tolerance Test | |
| Non pregnant people with normal glucose tolerance | Non pregnant population with normal Oral Glucose Tolerance Test results. Receives: Diagnostic Test: Oral Glucose Tolerance Test | |
| pregnant people with gestational diabetes mellitus | Pregnant people who meet the diagnosis of gestational diabetes. Receives: Diagnostic Test: Oral Glucose Tolerance Test | |
| pregnant people with normal glucose tolerance | Pregnant people with normal Oral Glucose Tolerance Test results. Receives: Diagnostic Test: Oral Glucose Tolerance Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and types of proteins/peptides differential characteristic peaks
Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis.
Measured: one year
Secondary outcomes (1)
ROC curve and area under curve AUC of clinical predictive diagnostic model
Construct a clinical predictive diagnostic model based on the obtained proteins/peptides differential feature peaks and calculate the area under the ROC curve AUC to evaluate the predictive effect of the model.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start20 May 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrediabetesStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 2,860 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Zhou, Professor, Study chair, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097065
- Sponsor's protocol ID
- Zhujiangzx
- Status last verified
- Feb 2023
- First submitted
- 9 Oct 2023
- Last updated
- 24 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on Potential Biomarkers of Prediabetes and Diabetes Based on MALDI-TOF MS Platform.
- ClinicalTrials.gov ID
- NCT06097065
- Acronym / sponsor ID
- Zhujiangzx
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,860 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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), impaired glucose tolerance (IGT) or both. It is a very important high-risk group of diabetes. Diabetes is a group of metabolic diseases characterized by hyperglycemia caused by a variety of causes. Gestational diabetes mellitus refers to varying degrees of abnormal glucose metabolism that occur during pregnancy. This project aims to detect differential feature peaks through MALDI-TOF MS technology 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 and to establish a clinical predictive diagnostic model based on differences, and to evaluate the model.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non pregnant people with prediabetes or diabetes | – | Diagnostic Test: Oral Glucose Tolerance TestNon pregnancy meeting the diagnosis of prediabetes or diabetes. |
| Non pregnant people with normal glucose tolerance | – | Diagnostic Test: Oral Glucose Tolerance TestNon pregnant population with normal Oral Glucose Tolerance Test results. |
| pregnant people with gestational diabetes mellitus | – | Diagnostic Test: Oral Glucose Tolerance TestPregnant people who meet the diagnosis of gestational diabetes. |
| pregnant people with normal glucose tolerance | – | Diagnostic Test: Oral Glucose Tolerance TestPregnant people with normal Oral Glucose Tolerance Test results. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- (1) cases: Non pregnant people: the remaining fasting serum/plasma and urine samples of prediabetes/diabetes patients; Pregnant people: the remaining fasting serum/plasma and urine samples of gestational diabetes patients. (2) controls: (Non)pregnant people: the remaining fasting serum/plasma and urine samples of normal population.
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (2 listed)
- 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.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Glucose Tolerance TestGrouping based on detected oral glucose tolerance test results without any other intervention. | Diagnostic test | Non pregnant people with normal glucose tolerance, Non pregnant people with prediabetes or diabetes, pregnant people with gestational diabetes mellitus, pregnant people with normal glucose tolerance |
Primary outcome
Number and types of proteins/peptides differential characteristic peaks
Time frame: one year
Obtain the number and types of proteins/peptides differential characteristic peaks between the case group and the control group through data analysis.
1 secondary outcome
ROC curve and area under curve AUC of clinical predictive diagnostic model
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongwei Zhou, Professor study chair
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prediabetes and Diabetes Mellitus, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nianyi Zeng (13928801657 ext. +86, zengny1@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and types of proteins/peptides differential characteristic peaks (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.