Gestational Diabetes MellitusNCT05670548
Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus
An observational study of Gestational Diabetes Mellitus, run by Women's Hospital School Of Medicine Zhejiang University at 1 site in China.
Trial summary
This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. Read more about this study
- Who is it for?
- Ages 20 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- Questionnaire survey and specimen collection
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Dec 2025
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This project intends to recruit pregnant women with GDM who go to the research center for routine prenatal examination and OGTT screening at 24-28 gestational weeks.
Who may be able to join
- Plan to have routine prenatal examinations and give birth in the research center
- GDM was diagnosed at 24-28 gestational weeks
- Singleton pregnancy
- Without other pregnancy complications
- Willing to cooperate with the hospital to follow up
Who cannot join
- Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
- Fetus has a known deformity or genetic defects
- Incomplete clinical data
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
Zhaoxia Liang, Prof., 86571-89992115, xiaozaizai@zju.edu.cn
About this study
Official title: Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus Based on Gestational Metabolic Profile and Lipid Profile
This project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Questionnaire survey and specimen collection
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire survey and specimen collectionOther
A questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery.
| Study group | Role | What they receive |
|---|---|---|
| Abnormal postpartum glucose metabolism | GDM with positive OGTT results at 6-12 weeks postpartum Receives: Other: Questionnaire survey and specimen collection | |
| Control | GDM with negative OGTT results at 6-12 weeks postpartum Receives: Other: Questionnaire survey and specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum lipidomics
The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.
Measured: During the 24-28 geatational weeks.
Serum metabolomics
The differential serum metabolism molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.
Measured: During the 24-28 geatational weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zhaoxia Liang, Prof., Study director, Women's Hospital School Of Medicine Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670548
- Sponsor's protocol ID
- IRB-20220336-R
- Status last verified
- Jan 2023
- First submitted
- 1 Jan 2023
- Last updated
- 4 Jan 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 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Postpartum Glucose Metabolism Abnormalities in Gestational Diabetes Mellitus Based on Gestational Metabolic Profile and Lipid Profile
- ClinicalTrials.gov ID
- NCT05670548
- Acronym / sponsor ID
- IRB-20220336-R
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Jan 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 project is expected to screen reliable serum markers in pregnant women with gestational diabetes mellitus (GDM) by using metabolic profiling and lipid profiling clinical high-throughput mass spectrometry technology. We intend to build an early pregnancy prediction model for postpartum glucose metabolism abnormalities of GDM. At the same time, this project plans to develop a predictive management system based on this model, so that it can be widely used in clinical detection process, realize the advance of the early warning window period of abnormal glucose metabolism, and provide theoretical guidance for the early postpartum blocking of GDM to the outcome of abnormal glucose metabolism.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abnormal postpartum glucose metabolism | – | Other: Questionnaire survey and specimen collectionGDM with positive OGTT results at 6-12 weeks postpartum |
| Control | – | Other: Questionnaire survey and specimen collectionGDM with negative OGTT results at 6-12 weeks postpartum |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This project intends to recruit pregnant women with GDM who go to the research center for routine prenatal examination and OGTT screening at 24-28 gestational weeks.
Key inclusion criteria (5 listed)
- Plan to have routine prenatal examinations and give birth in the research center
- GDM was diagnosed at 24-28 gestational weeks
- Singleton pregnancy
- Without other pregnancy complications
- Willing to cooperate with the hospital to follow up
Key exclusion criteria (3 listed)
- Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, heart disease, liver and kidney diseases, thyroid diseases with drug, autoimmune diseases, malignant tumors, AIDS, etc.
- Fetus has a known deformity or genetic defects
- Incomplete clinical data
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 |
|---|---|---|
| Questionnaire survey and specimen collectionA questionnaire survey was conducted when pregnant women were enrolled, and blood were collected at 24-28 gestational weeks. Placenta and umbilical cord blood are collected during delivery. | Other | Abnormal postpartum glucose metabolism, Control |
Primary outcome
Serum lipidomics
Time frame: During the 24-28 geatational weeks.
The differential serum lipid molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.
Serum metabolomics
Time frame: During the 24-28 geatational weeks.
The differential serum metabolism molecules in serum were detected by the self-developed detection chip, and the markers related to postpartum glucose metabolism abnormalities in GDM were screened. Specimens were collected during the 24-28 geatational weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 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.
Zhaoxia Liang, Prof. study director
Women's Hospital School Of Medicine Zhejiang University
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 Gestational Diabetes Mellitus, run by Women's Hospital School Of Medicine 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 5 inclusion and 3 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 4 Jan 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 Zhaoxia Liang, Prof. (86571-89992115, xiaozaizai@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum lipidomics (time frame: During the 24-28 geatational weeks.). The study lists 2 primary outcomes in all. 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 4 Jan 2023.