Gestational Diabetes MellitusNCT05388721
Correlation Between Environmental Pollution and 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
Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. 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?
- Clinical data and specimen collection
- How many people
- 2,500 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 31 Dec 2023
- 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 who go to the research center for routine prenatal examination and OGTT screening.
Who may be able to join
- Plan to complete OGTT and give birth in the research center
- First trimester
- Singleton pregnancy
- Without diabetes before pregnancy
Who cannot join
- Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, 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
- Assisted reproductive
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
Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. However, the etiology of GDM remains unclear. Various pollutants in the environment may have a potential impact on pregnant women and fetuses. For example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with GDM. At present, we plan to further investigate the correlation between environmental pollutants and GDM.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- Clinical data 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.
Clinical data and specimen collectionOther
Questionnaire survey and clinical data was conducted when pregnant women were enrolled in the first trimester, and blood and urine were collected. Furthermore, we will follow up the pregnant women until delivery, blood and urine were collected during the third trimester (after 28 weeks), and clinical information was collected.
Umbilical cord blood and placental tissue will be collected if possible.
| Study group | Role | What they receive |
|---|---|---|
| GDM group | Pregnant women with positive OGTT results at 24-28 gestational weeks Receives: Other: Clinical data and specimen collection | |
| Control group | Pregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group Receives: Other: Clinical data and specimen collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Environmental contaminants 1
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the first trimester and tested when classified in the GDM or control group
Measured: First trimester (9-14 gestational weeks)
Environmental contaminants 2
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the third trimester.
Measured: Third trimester (after 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 posted24 May 2022
- Study start1 May 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388721
- Sponsor's protocol ID
- Environment2022
- Status last verified
- Dec 2022
- First submitted
- 15 May 2022
- Last updated
- 16 Dec 2022
- 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 16 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Environmental Pollution and Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05388721
- Acronym / sponsor ID
- Environment2022
- Conditions
- Gestational Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Women's Hospital School Of Medicine Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 May 2022 (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.
Gestational diabetes mellitus (GDM) refers to the abnormal glucose metabolism index of pregnant women during pregnancy. At present, about 15% of pregnant women will develop GDM in the second and third trimester, which seriously affects the health of the pregnant woman and the fetus. However, the etiology of GDM remains unclear. Various pollutants in the environment may have a potential impact on pregnant women and fetuses. For example, previous studies have shown that exposure to atmospheric pollutants nitric oxide and organochlorine pesticides are associated with GDM. At present, we plan to further investigate the correlation between environmental pollutants and GDM.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM group | – | Other: Clinical data and specimen collectionPregnant women with positive OGTT results at 24-28 gestational weeks |
| Control group | – | Other: Clinical data and specimen collectionPregnant women with negative OGTT results at 24-28 gestational weeks, and had baseline data that matched those in the GDM group |
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 who go to the research center for routine prenatal examination and OGTT screening.
Key inclusion criteria (4 listed)
- Plan to complete OGTT and give birth in the research center
- First trimester
- Singleton pregnancy
- Without diabetes before pregnancy
Key exclusion criteria (4 listed)
- Have diseases that affect metabolic function or even threaten the life of the mother and fetus before pregnancy, such as diabetes, hypertension, 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
- Assisted reproductive
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 |
|---|---|---|
| Clinical data and specimen collectionQuestionnaire survey and clinical data was conducted when pregnant women were enrolled in the first trimester, and blood and urine were collected. Furthermore, we will follow up the pregnant women until delivery, blood and urine were collected during the third trimester (after 28 weeks), and clinical information was collected. Umbilical cord blood and placental tissue will be collected if possible. | Other | Control group, GDM group |
Primary outcome
Environmental contaminants 1
Time frame: First trimester (9-14 gestational weeks)
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the first trimester and tested when classified in the GDM or control group
Environmental contaminants 2
Time frame: Third trimester (after 28 gestational weeks)
The concentrations of environmental pollutants, such as organochlorine pesticides, polychlorinated biphenyls, polycyclic aromatic hydrocarbons, polybrominated diphenyl ethers and metallic elements, in serum and urine were analyzed by gas chromatochromatograms and mass spectrometry (GC-MS/MS). Specimens were collected during the third trimester.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2022.
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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 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 4 inclusion and 4 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 16 Dec 2022. 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?
Environmental contaminants 1 (time frame: First trimester (9-14 gestational 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 16 Dec 2022.