GDMNCT05881616
Study on Serum Metabolomics of GDM
An observational study of GDM and Pathogenesis, run by Zhejiang University at 1 site in China.
Trial summary
This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- GDM, Pathogenesis, Diagnosis
- What is being tested?
- Specimen samples and baseline data collection
- Type of treatment
- Pill or oral medicine
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 18 Jul 2023to May 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This study aims to recruit pregnant women undergoing routine prenatal examinations and healthy women undergoing routine physical examination.
Who may be able to join
- No obvious abnormalities in all inspection items
- No history of diabetes
- No particular dietary habits
- No previous history of other mental illnesses
- No history of drug abuse or allergies
- No history of smoking or drinking
Who cannot join
- Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
- Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
- Personal history of syphilis, HIV positive, and other infectious diseases
- Artificial insemination or IVF pregnancy
- Multiple pregnancy (twins or more)
- Patients participating in other clinical studies
- Other reasons that researchers think are inappropriate
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Women's Hospital School Of Medicine Zhejiang University
Hangzhou, Zhejiang, 310006
HU Xiaoli
About this study
Official title: Serum Metabolomics Analysis for Early Diagnosis and Pathogenesis of Gestational Diabetes Mellitus
This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.
- Conditions
- GDM, Pathogenesis, Diagnosis
- Being tested
- Specimen samples and baseline data collection
- Keywords
- Metabolomics
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen samples and baseline data collectionOther
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.
Specimen samples and baseline data collectionOther
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.
Specimen samples and baseline data collectionOther
The remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age.
| Study group | Role | What they receive |
|---|---|---|
| GDM group | Pregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks. Receives: Other: Specimen samples and baseline data collection | |
| non-GDM group | Pregnant women aged 20-40 with negative OGTT results at 24-28 weeks. Receives: Other: Specimen samples and baseline data collection | |
| Control group | Healthy non-pregnant women aged 20-40. Receives: Other: Specimen samples and baseline data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Content of serum metabolomics
Based on non-targeted metabolomics technology, the metabolites in serum were comprehensively detected. Differential metabolites were screened using multivariate statistical analysis. Then quantitatively detect the content of these metabolites to find the differential metabolites with predictive ability for GDM.
Measured: Second trimester (24-28 gestational weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2023
- Study start18 Jul 2023
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GDMStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 480 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University
- Responsible party
- Principal investigator, Lu LI, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05881616
- Sponsor's protocol ID
- IRB-20230193-R
- Status last verified
- Jul 2023
- First submitted
- 19 May 2023
- Last updated
- 24 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Serum Metabolomics Analysis for Early Diagnosis and Pathogenesis of Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05881616
- Acronym / sponsor ID
- IRB-20230193-R
- Conditions
- GDM, Pathogenesis, Diagnosis
- Keywords
- Metabolomics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Women's Hospital School Of Medicine Zhejiang University
- Study start
- 18 Jul 2023 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 31 May 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.
This study aims to collect serum samples from healthy non-pregnant women, pregnant women with and without Gestational Diabetes Mellitus (GDM). We will analyze the metabolite changes among the three groups using clinical metabolomics and identify potential biomarkers and metabolic pathways. This study will provide scientific evidence for early clinical diagnosis, prevention, control, and treatment research of GDM.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GDM group | – | Other: Specimen samples and baseline data collectionPregnant women aged 20-40 with positive oral glucose tolerance test (OGTT) results at 24-28 weeks. |
| non-GDM group | – | Other: Specimen samples and baseline data collectionPregnant women aged 20-40 with negative OGTT results at 24-28 weeks. |
| Control group | – | Other: Specimen samples and baseline data collectionHealthy non-pregnant women aged 20-40. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This study aims to recruit pregnant women undergoing routine prenatal examinations and healthy women undergoing routine physical examination.
Key inclusion criteria (6 listed)
- No obvious abnormalities in all inspection items
- No history of diabetes
- No particular dietary habits
- No previous history of other mental illnesses
- No history of drug abuse or allergies
Key exclusion criteria (7 listed)
- Pregnancy complications such as uterine fibroids, hyperthyroidism/hypothyroidism, and antiphospholipid antibody syndrome
- Critical illnesses such as cardiovascular disease or abnormal liver/kidney function
- Personal history of syphilis, HIV positive, and other infectious diseases
- Artificial insemination or IVF pregnancy
- Multiple pregnancy (twins or more)
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 |
|---|---|---|
| Specimen samples and baseline data collectionThe remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age. | Other | GDM group |
| Specimen samples and baseline data collectionThe remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age. | Other | non-GDM group |
| Specimen samples and baseline data collectionThe remaining serum samples from routine blood tests of subjects will be collected (without additional blood collection), with a serum sample size of approximately 1 mL per subject. The samples will be pre-processed and stored at ultra-low temperatures. At the same time, clinical baseline data of subjects will be collected from outpatient or inpatient medical records, including but not limited to age, height, weight, blood pressure, and gestational age. | Other | Control group |
Primary outcome
Content of serum metabolomics
Time frame: Second trimester (24-28 gestational weeks)
Based on non-targeted metabolomics technology, the metabolites in serum were comprehensively detected. Differential metabolites were screened using multivariate statistical analysis. Then quantitatively detect the content of these metabolites to find the differential metabolites with predictive ability for GDM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 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. This study is not recruiting at the moment.
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 GDM and Pathogenesis, run by Zhejiang University 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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 24 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LI Lu, Dr. (0571-88208596, luciali@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content of serum metabolomics (time frame: Second trimester (24-28 gestational weeks)). 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 Jul 2023.